final car - echadissemination.echa.europa.eu/.../1377-18/section_1-5.pdfa2 of dossier chemical...

Regulation (EU) No 528/2012 concerning the makingavailable on the market and use of biocidal products

Evaluation of active substance

Competent Authority Report

Document IIIA

Silicon dioxide Kieselguhr or Diatomaceous Earth(61790-53-2)

Product type 18: Insecticides, Acaricides and products tocontrol other arthropods

Final CAR

November 2015

RMS: FRANCE

Silicon dioxide Kieselguhr PT18 Final CAR document IIIA November 2015




Document IIIA

Silicon dioxide Kieselguhr or Diatomaceous Earth(61790-53-2)

Analytical methods and physico-chemicalproperties

Final CAR

Silicon dioxide Kieselguhr PT18 Final CAR document IIIA November 2015

Section A1Annex Point IIA, I 1

Applicant

1.1 Applicant Company name:Address:

BIOFA AG

Telephone:Fax number:

++

E-mail address:- XXXX- XXXX

1.2 Manufacturer ofActive Substance(if different)

Manufacturer:Address:

Biofa AG

Telephone:Fax number:E-mail address:

++

1.3 Manufacturer ofProduct(s)(if different)

Location of manufacturing plant:

XXXX

Silicon dioxide Kieselguh1· PT 18 Final CAR document IIIA November 2015

Section At Applicant

Annex Point IIA, I 1

Evaluation by Competent Authorities

Use separate "evaluation boxes" to provide transparency as to the comments and views submitted

EVALUATION BY RAPPORTEUR MEMBER STATE

Date xxxx Materials and metl1ods

Conclusion xxxx

Reliability

Acceptability

Remarks

COMMENTS FROM ...

Date Give date of comments submitted

Results and discussion Discuss additional relevant discrepancies referring to the (sub)heading numbers and to applicant's summary and conclusion. Discuss if deviating from view of rapporteur member state

Conclusion Discuss if deviating from view of rapporteur member state

Reliability Discuss if deviating from view of rapporteur member state

Acceptability Discuss if deviating from view of rapporteur member state

Remarks

Page4

Silicon dioxide Kieselguhr PT 18 Final CAR- DOC IIIA November 2016

Section A2 Identity Subsection A2.3 MANUFACTURER'S DEVELOPMENT CODE NUMBER Annex Point IIA, II 2.3

JUSTIFICATION FOR NON-SUBMISSION OF DATA Official use only

Other existing data [ ... ] Technically not feasible [ l Scientifically unjustified [ l Limited exposure [ l Other justification [X]

Detailed justification: A manufacturer's development code number cannot be provided for Diatomaceous earth (DE) since such number is not available for the active substance.

Undertaking of intended -d.ata submission [ l




Date :xxxx Evaluation of applicant's :xxxx justification

Conclusion :xxxx Remarks

COMMENTS FROM OTHER MEMBER STATE (specify)


Evaluation of applicant's Discuss if deviating from view of rapporteur member state justification


Remarks

Page 1

Section A2 Identity Subsection A2.4 CAS NO AND EC NUMBERS Annex Point IIA, II 2.4


Other existing data [ ... ] Technically not feasible [ l Scientifically unjustified [ l Limited exposure [ l Other justification [X]

Detailed justification: The CAS number is given for the active substance Diatomaceous earth (DE) as manufactured. Other numbers, for example EC number or CIP AC number, are not submitted because such numbers are not

I allocated for it.

Undertaking of intended -

I d.ata submission [ l




Date xxxx Evaluation of applicant's xxxx justification

Conclusion xxxx Remarks

COMMENTS FROM OTHER M EMBER STATE (specify)




Remarks

Page l

Section A2 Subsection A2.8 Annex Point IIA, II 2.8

Date

Evaluation of applicant's justification

Conclusion

Remarks

Date

Results and discussion

Conclusion

Reliability

Acceptability

Remarks

Identity of impurities and additives (active substance)

This infonnation is confidential and therefore provided separately in the confidential part of the dossier.




:xxxx :xxxx

:xxxx

COMMENTS FROM ...

Give date of comments submitted

Official use only

Discuss additional relevant discrepancies refening to the (sub)heading numbers and to applicant's s11mma1y and conclusion. Discuss if deviating/ram view of rapporteur member state

Discuss if deviating/ram view of rapporteur member state

Discuss if deviatingfrom view of rapporteur member state

Discuss if deviating/ram view of rapporteur member state

Page 1




Silicon dioxide Kieselgurh or Diatomaceous Earth

CAS N°:61790-53-2


Analytical methods and Physico-chemical properties

September 2016

Revised CAR

RMS: FRANCE

Silicon dioxide Kieselguhr or Diatomaceous Eruth

Product-types 18 September 2016

Section A2 Identity Subsection A2.8.5 OTHER NUMBERS Annex Point IIA, II 2.8


Other existing data [ l Technically not feasible [ l Scientifically unjustified [ l Limited exposure [ l Other justification [X]

Detailed justification: CAS numbers and EC numbers, respectively, are given for the ingredients ofDiatomaceous earth (DE), where possible. Other numbers, for example CIP AC numbers, are not submitted because such numbers are not allocated for them.









Evaluation of applicant's Discuss if deviatingfrom view of rapporteur member state justification

Conclusion Discuss if deviatingfrom view of rapporteur member state

Remarks

Page2

Section A2 Annex point IIA, II 2

Subsection (Annex Point)

2.1 Common name (IIA2.1)

2.2 Chemical name (IIA2.2)

2.3 Manufactm·e1·'s development code number(s) (IIA2.3)

2.4 CAS No and EC numbers (IIA2.4)

2.4.1 CAS-No

Isomer 1

Isomer n

2.4.2 EC-No

Isomer 1

Isomer n

2.4.3 Othe1·

2.5 Molecular and structural fo1·mula, molecular mass (IIA2.5)

2.5.1 Molecular formula

2.5.2 Structural formula

2.5.3 Molecular mass

2.6 Method of manufacture of the active substance (IIA2.1)

Identity of Active Substance

Common name: Diatomaceous earth (DE)

Synonym: Kieselgur

Chemical name of the main component of Diatomaceous earth:

Amorphous silicon dioxide

No manufacturer's development code number is available for the active substance.

61790-53-2

Not allocated

Not allocated

xxxx

xxxx

60.08 g/mol (Si02)

The method of manufacture of the active substance is confidential. This info1mation is provided separately in the confidential part of the dossier.

Page 1

Official use only

Section A2 Annex point IIA, II 2

2.7

2.8

Specification of the purity of the active substance, as appropriate (IIA2.7)

Identity of impm·ities and additives, as appropriate (IIA2.8)

2.8.1 Isomeric composition

2.9 The 01·igin of the natural active substance 01· the precursor(s) of the active substance (IIA2.9)

Identity of Active Substance

This infonnation is confidential and provided separately in the confidential part of the dossier.

Representative production batches ofDiatornaceous earth were analysed.

This infonnation is confidential and provided separately in the confidential part of the dossier.

Not relevant

xxxx

Page2

xxxx

xxxx

Section A2 Identity of Active Substance Annex point IIA, II 2

Evaluation by Competent Authorities Use separate "evaluation boxes" to provide transparency as to the conunents and views submitted

EVALUATION BY RAPPORTEUR MEMBER

Date xxxx Mate1·ials and methods xxxx

Conclusion xxxx

Reliability xxxx Acceptability xxxx

Remarks

COMMENTS FROM ...


Results and discussion Discuss additional relevant discrepancies refening to the (sub)heading numbers and to applicant's summa1y and conclusion. Discuss if deviating from view of rapporteur member state




Remarks

Page 3

Section A3 Physical and C hemical Properties of Active Substance

Subsection Method Purity/ Results Remar ks/ G LP Reliability Reference Officia l (Annex Point) Specification Justification (YIN) use only

3.1 Melting point, boiling point, relative density (llA3. I)

3.1.1 Melting point International standard Specification as 1710 °C - N 2 International xx.xx given in Section Program on A2 of dossier Chemical Safety,

2001

3.1.2 Boiling point International standard Specification as > 2200 °C - N 2 International xx.xx given in Section Program on A2 of dossier Chemical Safety,

2001

3.1.3 Bulk density/ International standard Specification as 128-320 g/L - N 2 Anderson, 1990 xx.xx relative density given in Section

A2 of dossier

International standard Specification as 80-256 g/L - N 2 Moyle and Dolley, xx.xx given in Section 2003 A2 of dossier

As a result of the literature data, the density of DE varies between 80-320 g/L, depending on the geographical origin.

3.2 Vapou r pressu re International standard Specification as Vapour pressure is - N 2 Hazardous xx xx (IIA3.2) given in Section estimated to be Substances Data

A2 of dossier OmmHg. Bank, 2006

3.2.1 Henry's Law - - - The active - - -Consta nt substance is not {III 3.2) volatile.

3.3 A ppeara nce (IIA3.3)

Page I


Subsection Method Purity/ Results Remar ks/ GLP Reliability Reference Officia l (Annex Point) Specification Justification (YIN) use only

3.3.1 Physical state Visual inspection Specification as Solid (dust) - N 2 Korunic, 1998 xx.xx given in Section A2 of dossier

3.3.2 Colour Visual inspection Specification as DE varies in colour - N 2 Korunic, 1998 xx.xx given in Section depending on A2 of dossier composition, from white

grey to yellow to red.

3.3.3 Odour Olfactory inspection Specification as Odourless - N 2 Korunic, 1998 xx.xx given in Section A2 of dossier

3.4 Absorption spectra (IIA3.4)

UV/VIS - - - Not applicable - - -because active substance is not soluble in water and organic solvents.

IR xx.xx Specification as xxxx - xxxx xxxx xxxx xx.xx given in Section A2 of dossier

NMR xx.xx Specification as xxxx - xxxx xxxx xxxx xx xx given in Section A2 of dossier

Page 2



MS - - - Not applicable - - -because active substance is not soluble in water and organic solvents.

X-ray xx.xx Specification as xxxx - xxxx xxxx xx xx xx.xx given in Section A2 of dossier

3.5 Solubility in water International standard Specification as The active substance is - N 2 Korunic, 1 998 and xx.xx (ll A3.5) given in Section insoluble in water. Hazardous

A2 of dossier Substances Data Bank,2006

xx.xx Specification as xxxx xx xx xx.xx xx xx x given in Section x A2 of dossier x

x

3.6 Dissociation constant - - - Not applicable - - -(-) because active

substance is not soluble in water.

Page 3


Subsection Method Purity/ Results Remarks/ GLP Reliability Reference Officia l (Annex Point) Specification Justification (YIN) use only

3.7 Solubili ty in organic xx.xx Specification as xx.xx xxxx xx.xx xxx:x xx xx xx.xx solvents, including given in Section the effect of A2 of dossier temperature on solubility (lllA3.1)

3.8 Stability in organic - - - Not applicable - - -solvents used in b.p. because active and identity of substance does relevant breakdown not include an products organic solvent. (lllA3.2)

3.9 Partition coefficient - - - Not applicable - - -n-octanol/water because active (ll A3.6) substance is not

soluble in water and organic solvents.

Page4


Subsection Method Purity/ Results Remarks/ GLP Reliability Reference Officia l (Annex Point) Specification Justification (YIN) use only

3.10 Thermal stability, xx.xx Specification as xxxx xxxx xxxx xxxx xx xx xx.xx identity of relevant given in Section breakdown products A2 of dossier (ll A3.7)

3.11 Fla mma bility, - - - Not performed - - -including a uto- because active flammability and substance has no identity of flammable co mbustion products properties. (ll A3.8)

3.12 Flash-point - - - Not applicable - - -(IIA3.9) because active

substance is solid.

Page 5



3.13 S urface tension - - - Not applicable - - -(llA3. IO) because active

substance is not soluble in water.

3.14 Viscosity - - - Not applicable - - -(-) because active

substance is solid.

3.15 Explosive properties - - - Not performed - - -(ll A3.11) because active

substance does not present any risk for explosion.

3.16 Oxidizing properties - - - Not performed - - -(ll A3.12) because active

substance does not present oxidising properties.

3.17 Reactivity towards International standard Specification as The active substance is - N 2 Moyle and Dolley, xx xx container material given in Section a chemically inert 2003 (ll A3.13) A2 of dossier material.

Not applicable 100% DE Judged from experience - - - - xx xx (statement based on Specification as in use since many years experience) given in Section the active substance is

A2 of dossier not reactive towards the following container materials: HDPE, LDPE and paper.

3.18 Ot her studies

Page 6



Particle size xx.xx Specification as xxxx xxxx xxxx xxxx xxxx xx.xx distribution given in Section

A2 of dossier

Specific surface area xx xx Specification as xxxx xx xx xxxx xxxx xx.xx given in Section xxxx A2 of dossier

Page 7

Diatomaceous earth (DE) PT 18 September 2015

Page 8

Diatomaceous earth (DE) PT 18 • September 2015

Date

Materials and methods

Evaluation by Competent Authorities Use separate "evaluation boxes" to provide transparency as to the comments and views submitted


:xxxx :xxxx

:xxxx

:xxxx

:xxxx

:xxxx

:xxxx

Page 9


Page 10


Page 11

Conclusion

Reliability

Acceptability

Remarks

COMMENTS FROM ...


Page 12


Results and discussion Discuss additional relevant discrepancies referring to the (sub)heading numbersand to applicant´s summary and conclusion.Discuss if deviating from view of rapporteur member state




Remarks




Silicon dioxide Kieselgurh or Diatomaceous Earth

CAS N°:61790-53-2


Analytical methods and Physico-chemical properties

September 2016

Revised CAR

RMS: FRANCE

Silicon dioxide Kieselguhr or Diatomaceous Eruth

Product-types 18 September 2016

Section A3 Physical and chemical properties of the active substance Subsection A3.2.1 HENRY'S LAW CONSTANT Annex Point IIA, III 3.2


Other existing data [ l Technically not feasible [ ... ] Scientifically unjustified [ l

I Limited exposure [ l Other justification [X]

Detailed justification: According to the Technical Notes for Guidance on Data Requirements the Heruy's law constant must always be stated for the active substance if it can be calculated.

The Heruy's law constant depends on the vapour pressure and the water solubility of a substance, and express the tendency to evaporate from aqueous solutions.

Since the vapour pressure of Diatomaceous earth (DE) was estimated to be 0 mm Hg and the active substance is not soluble in water, a calculation of the Heruy's law constant is not possible.

But based on the results of vapour pressure and the water solubility it can be concluded that the active substance DE is not volatile and shows no tendency to evaporate from aqueous solutions.


I d.ata submission [ l Evaluation by Competent Authorities




Conclusion xxxx

Remarks





Remarks

Section A3 Subsection A3.4 Annex Point IIA, III 3.4

Other existing data [ ]

Limited exposure [ ]

Detailed justification:

Physical and chemical properties of the active substance ABSORPTION SPECTRA

JUSTIFICATION FOR NON-SUBMISSION OF DATA

Technically not feasible [X]

Other justification [ ]

Scientifically unjustified [ ]

According to the Technical Notes for Guidance on Data Requirements abso1ption spectra (UVNIS and NMR) and a mass spectrum have to be determined for a purified active substance, where relevant.

The solubility of an active substance in water and I or organic solvents is the precondition for the detemlination of absorption and mass spectra.

The active substance Diatomaceous earth (DE) is not soluble in water (Korunic, 1998) and its solubility in organic solvents is unlikely due to its che1nical structure.

An examination of the structural formula establishes beyond reasonable doubt that DE is a highly stable compound.

xxxx xxxx Since DE shows no solubility in water and I or organic solvents, it is technically not feasible to detennine UVNIS-, NMR- and mass-spectra of the active substance.

Undertaking of intended -d.ata submission [ ]

Date


Conclusion

Remarks

Date


Conclusion

Remarks




xxxx xxxx

xxxx

xxxx



Discuss if deviating from view of rapporteur member state


Page 1

I

Official use only

Section A3 Physical and chemical properties of the active substance Subsection A3.6 DISSOCIATION CONSTANT Annex Point (-)


Other existing data [ l Technically not feasible [ ... ] Scientifically unjustified [ l


Detailed justification: According to the Technical Notes for Guidance on Data Requirements the dissociation constant of active substances should always be given if it can be determined. The test should be performed in accordance with OECD guideline 112.

Since the active substance Diatomaceous earth (DE) is not soluble in water (Korunic, 1998), a dete1mination of the dissociation constant does not apply.




EVALUATION BY RAPPORTEUR ME MBER STATE


Conclusion xxxx

Remarks

COMMENTS FROM OTHER MEMBE R STATE (specify)




Remarks

Page 1

Section A3 Subsection A3.7 Annex Point IIIA, III 1




Undertaking of intended d.ata submission [ ]

Date


Conclusion

Remarks

Date


Conclusion

Physical and chemical properties of the active substance SOLUBILITY IN ORGANIC SOL VENTS


Technically not feasible [X]


Scientifically unjustified [X]

Official use only

No studies have been conducted to investigate the solubility in organic XXXX solvents of the active substance Diatomaceous ea1th (DE) due to the following reason.

An examination of the structural formula establishes beyond reasonable doubt that the active substance DE is a highly stable compound.

xxxx Due to the high stability of the chemical stmcture, solubility of the active substance in organic solvents is unlikely and a determination therefore not possible.


Use separate "evaluation boxes" to provide transp arency as to the comments and views submitted


xxxx xxxx

xxxx

COMMENTS FROM OTHER MEMBER STATE (sp ecify)



Discuss if deviating f rom view of rapporteur member state

Page I

Section A3Subsection A3.7Annex Point IIIA, III 1

Physical and chemical properties of the active substanceSOLUBILITY IN ORGANIC SOLVENTS

Remarks

Section A3 Physical and chemical properties of the active substance Subsection A3.8 STABILITY IN ORGANIC SOLVENTS Annex Point IIIA, III 2


Other existing data [ l Technically not feasible [ l Scientifically unjustified [ l


Detailed justification: According to the Technical Notes for Guidance on Data Requirements the stability of active substances in organic solvents must be stated if the active substance includes an organic solvent.

Since the active substance Diatomaceous earth (DE) does not include an organic solvent it is justified not to perform a study for detennination of stability in organic solvents.






Conclusion xxxx

Remarks





Remarks

Page I

Section A3 Physical and chemical properties of the active substance Subsection A3.9 PARTITIONCOEFFICIENTN-OCTANOL / WATER Annex Point IIA, III 3.6


Other existing data [ l Technically not feasible [X] Scientifically unjustified [ l

I Limited exposure [ l Other justification [ l

Detailed justification: The solubility of an active substance in water and n-octanol is the precondition for the determination of the partition coefficient n-octanol I water.

The active substance Diatomaceous earth (DE) is not soluble in water (Korunic, 1998) and its solubility in organic solvents is unlikely due to its chernical structure.

An examination of the structural formula establishes beyond reasonable doubt that the active substance DE is a highly stable compound

xxxx

Since DE shows no solubility in water and I or organic solvents, it is technically not feasible to determine the partition coefficient n-octanol I water of the active substance.

I Undertaking of intended -d.ata submission [ l










Remarks

Page 1

Section A3 Subsection A3.10 Annex Point IIA, III 3. 7




Physical and chemical properties of the active substance THERMAL ST ABILITY


Technically not feasible [ ]



According to the Technical Notes for Guidance on Data Requirements the thennal stability of active substances is to be identified to the point of melting, sublimation or decomposition according to OECD guideline 113. In accordance v.iith this guideline an active substance is not stable at room temperature if either melting point does not remain constant or content of active substance decreased by more than 5% during stability test for 14 days at 54 °C or decomposition or chemical transfonnation is found below 150 °C.

No studies have been conducted to investigate the thermal stability of the active substance Diatomaceous earth (DE) due to the following reasons:

An examination of the structural formula establishes beyond reasonable doubt that the active substance Diatomaceous earth (DE) is a highly stable compound.

xxxx Fmthennore the melting point of DE is 1710 °C (IPCS, 2001) .

Thus it is unlikely that the active substance does not fulfil the above mentioned criteria of OECD guideline 113.

Stmctural fonnula and melting point do not indicate any thennal instability of DE at room temperature and therefore a test for the1mal stability is scientifically unjustified.


Page 1

I

Official use only

Section A3 Physical and chemical properties of the active substance Subsection A3.10 THERMAL ST ABILITY Annex Point IIA, III 3. 7




Conclusion xxxx

Remarks





Remarks

Page2

Section A3 Subsection A3.11 Annex Point IIA, III 3.8




Physical and chemical properties of the active substance FLAMMABILITY


Technically not feasible [ ]

Other justification [X]


No studies have been conducted to investigate the flammability of the active substance Diatomaceous earth (DE) due to the following reasons:

According to the International Chemical Safety Card (IPCS, 2001) the active substance is not combustible.

An examination of stmctural fonnula es tablishes beyond reasonable doubt that the active substance DE is incapable of exothennic reaction and shows no flammable prope1t ies.

xxxx Thus the active substance is incapable of exothermic reaction.

Since DE is incapable of exothennic reaction a test for pyrophoric properties (EC method A.13) can be omitted.

According to the Technical Notes for Guidance on Data Requirements the auto-flallllllability of solid active substances must be detennined according to EC method A.16. The principle of this method is to record the temperature in the centre of a sample while the temperature of the oven is increased to 400 °C. The temperature of the oven at which the sample reaches 400 °C by self-heating is called the self-ignition temperature. Since the melting point of DE is 1710 °C (IPCS, 2001), a self-heating of the active substance during the test is unlikely.

Therefore it is justified not to perfo1m a test for auto-flammability.

The active substance Diatomaceous eaith (DE) is not soluble in water (Komnic, 1998). Therefore it is scientifically unjustified to investigate the reaction of the active substance with water according to EC method A.12.


Page 1

I

Official use only

Section A3 Physical and chemical properties of the active substance Subsection A3.11 FLAMMABILITY Annex Point IIA, III 3.8




Date xxxx Evaluation of applicant's justification xxxx

Conclusion xxxx

Remarks





Remarks

Page 2

Section A3 Physical and chemical properties of the active substance Subsection A3.12 FLASH POINT Annex Point IIA, III 3.9




Detailed justification: According to the Technical Notes for Guidance on Data Requirements

I the flash point must be provided for liquid active substances whose vapours can be ignited.

Since the active substance Diatomaceous earth (DE) is solid it is justified not to perform a study for determination of flash point.






Conclusion xxxx

Remarks





Remarks

Page I

Section A3 Physical and chemical properties of the active substance Subsection A3.13 SURF ACE TENSION Annex Point IIA, III 3.10


Other existing data [ l Technically not feasible [X] Scientifically unjustified [ l

I Limited exposure [ l Other justification [ l

Detailed justification: According to the Technical Notes for Guidance on Data Requirements the surface tension of active substances should be measured using an aqueous solution of sufficient concentration such that any surface activity potential is expressed.

The test must be performed in accordance v.iith EC method A.5 or OECD guideline 115. According to these guidelines substances with a water solubility lower than 1 mg/L need not be tested.

As known from the solubility in water study (Komnic, 1998) the active substance Diatomaceous earth (DE) is not soluble in water. Therefore it is technically not feasible to detemline the surface tension of the active substance.






Conclusion xxxx

Remarks





Remarks

Page 1

Section A3 Physical and chemical properties of the active substance Subsection A3.14 VISCOSITY Annex Point (-)




Detailed justification: According to the Technical Notes for Guidance on Data Requirements I the viscosity is always required for liquid active substances.

Since the active substance Diatomaceous earth (DE) is solid it is justified not to perform a study for determination of viscosity.






Conclusion xxxx

Remarks





Remarks

Page I

Section A3 Physical and chemical properties of the active substance Subsection A3.15 EXPLOSIVE PROPERTIES Annex Point IIA, III 3.11




Detailed justification: According to the Technical Notes for Guidance on Data Requirements

I the test for explosive prope1ties can be exempted when absence of ce1tain reactive groups in the structural formula establishes beyond reasonable doubt that the active substance is incapable of decomposing, fonning gases or releasing heat very rapidly.

Due to its chemical structure the active substance Diatomaceous earth (DE) does not contain reactive functional groups, like for example diazo, nitroso, nitro, epoxide, peroxide, azide, chlorate or perchlorate, in its molecular backbone which are known to confer explosivity to the substance or to enhance explosibility prope1ties.

Thus the active substance is incapable of rapid decomposition with evolution of gases or release of heat and does not present any risk for explosion.

Therefore it is justified not to perform a test for explosive properties.











Remarks

Page I

Section A3 Physical and chemical properties of the active substance Subsection A3.16 OXIDISING PROPERTIES Annex Point IIA, III 3.12




Detailed justification: According to the Technical Notes for Guidance on Data Requirements I the test for oxidising properties need not to be ca1ried out when examination of stmctural fonnula establishes beyond reasonable doubt that the active substance is incapable of reacting exothennically with combustible material.

Examination of the stmctural formula establishes that the active substance Diatomaceous ea1th (DE) does not contain oxidising groups or other chemically instable functional groups in its molecular backbone which are known to enhance oxidizing properties .

Thus the active substance may not react exothennically with a combustible material and does not have oxidising prope1t ies.

Therefore it is justified not to perform a test for oxidising properties.











Remarks

Page I

Silicon dioxide Kieselguhr PT 18 Final CAR Doc IIIA November2016

Section A4 Subsection A4.1 Annex Point IIA, IV 4.1

Analytical Methods for Detection and Identification ANALYTICAL METHOD FOR THE DETERMINATION OF PURE ACTIVE SUBSTANCE AND IMPURITIES IN THE ACTIVE SUBSTANCE AS MANUFACTURED

An analytical method for the determination of the active substance ingredients is available but confidential. Therefore the analytical method is provided separately in the confidential part of the dossier.

Page 1

Official use only

Silicon dioxide Kieselguhr PT 18 Final CAR Doc IIIA November2016

Section A4 Subsection A4.1 Annex Point IIA, IV 4.1

Date

Materials and methods

Conclusion

Reliability

Acceptability

Remarks

Analytical Methods for Detection and Identification ANALYTICAL METHOD FOR THE DETERMINATION OF PURE ACTIVE SUBSTANCE AND IMPURITIES IN THE ACTIVE SUBSTANCE AS MANUFACTURED




xxxx xxxx

xxxx

xxxx

xxxx xxxx xxxx

COMMENTS FROM ...

Page2

Silicon dioxide Kieselguhr PT 18 Final CAR Doc IIIA November 2016

Page 3

Section A4Subsection A4.1Annex Point IIA, IV 4.1

Analytical Methods for Detection and IdentificationANALYTICAL METHOD FOR THE DETERMINATION OF PUREACTIVE SUBSTANCE AND IMPURITIES IN THE ACTIVESUBSTANCE AS MANUFACTURED


Results and discussion Discuss additional relevant discrepancies referring to the (sub)heading numbersand to applicant´s summary and conclusion.Discuss if deviating from view of rapporteur member state




Remarks

Section A4.2 Analytical Methods for Detection and Identification Annex Point IIA, IV 4.2 ANALYTICAL METHOD FOR THE DETERMINATION OF ACTIVE

SUBSTANCE RESIDUES IN SOIL



Detailed justification: xxxx






Conclusion Indicate whether applicant's justification is acceptable or not. If unacceptable because of the reasons discussed above, indicate which action will be required, e.g. submission of specific test/study data

Remarks





Remarks

Page I

Section A4.2 Annex Point IIA, IV 4.2

1.1 Refer ence

1.2

1.2.1

1.2.2

2.1

2.2

2.3

Data protection

Data owner

Criteria for data protection

Guideline study

GLP

Deviations

3.1 P1·eliminary treatment

3 .1.1 Enrichment

3.1.2 Cleanup

3.2 Detection

Analytical Methods for Detection and Identification ANALYTICAL METHOD FOR THE DETERMINATION OF ACTIVE SUBSTANCE RESIDUES IN AIR

Dete11nination of am01pho11s silica content

1 REFERENCE

NIOSH (Ed.), 2003b, Silica, amorphous. NIOSH Manual of Analytical Methods (NMAM),fourth Edition, National Institute for Occupational Safety and Health, USA, Method No. 7501 , Issue 3 (published), date: 2003-03-15

No

Not applicable

Not applicable

2 GUIDELINES AND QUALITY ASSURANCE

No,

No guideline available.

No

No

3 MATERIALS AND METHODS

xxxx

Page 1

Official use only




3.2.1 Separation method XXXX

3.2.2 Detector XXXX

3.2.3 Standard(s) XXXX

3.2.4 Interfering xxxx substance( s)

3.3 Linea1ity

3.3.l Calibration range xxxx

3.3 .2 Number of xxxx measurements

3.3.3 Linearity xxxx

3.4 Specificity: xxxx interfe1ing substances

3.5 Recover y rates at xxxx differ ent levels

3.5.l Relative standard xxxx deviation

3.6 Limit of xxxx determination

3.7 P1·ecision

3.7.l Repeatability xxxx

3.7.2 Independent XXXX laboratory validation

4.1 Materials and methods

4.2 Conclusion

4 APPLICANT'S SUMMARY AND CONCLUSION

The content of amo1phous silica, the main component in the active substance Diatomaceous earth, in workplace air is detennined by means of X-ray diffraction after collecting a dust sample by drawing air at a defined volume through a polyvinyl chloride (PVC) filter cassette using a personal sampling pump.

The NIOSH Manual of Analytical Methods is a collection of methods for sampling and analysis of contaminants in workplace air. These methods have been developed or adapted by NIOSH or its partners and have been evaluated according to established experimental protocols and performance criteria.

The method is therefore considered to be valid for the detemlination of the amo1phous silica content ofDiatomaceous eait h in air.

Page2

xxxx


4.2 .1 Reliability

4.2 .2 Deficiencies

Date

Mate1·ials and methods

Conclusion

R eliability

Acceptability

Remarks

Date


Conclusion

Reliability

Acceptability

Remarks



Reliability indicator:XXXX

No




xxxx xxxx

xxxx

xxxx

xxxx xxxx

COMMENTS FROM ...


Discuss additional relevant discrepancies refe11ing to the (sub)heading numbers and to applicant's summaiy and conclusion. Discuss if deviatingfrom view of rapporteur member state




Page 3


1.1 Reference

1.2

1.2.1

1.2 .2

2.1

2.2

2.3

Data protection

Data owner

Criteria for data protection

Guideline study

GLP

Deviations

3.1 P1·eliminary treatment

3 .1.1 Enrichment

3.1.2 Cleanup

3.2 Detection

3.2 .1 Separation method

3.2 .2 Detector

3.2 .3 Standard(s)

3.2 .4 Interfering substance( s)

3.3 Linea1ity

Analytical Methods for Detection and Identification ANALYTICAL METHOD FOR THE DETERMINATION OF

ACTIVE SUBSTANCE RESIDUES IN AIR

xxxx

1 REFERENCE

xxxx

No

Not applicable

Not applicable

2 GUIDELINES AND QUALITY ASSURANCE

No,

No guideline available.

No

No

3 MATERIALS AND METHODS

xxxx

xxxx

xxxx xxxx

xxxx

Page 1

Official use only


3.3. l Calibration range

3.3.2 Number of measw·ements

3.3.3 Linearity

3.4 Specificity: interfe1ing substances

3.5 Recover y rates at differ ent levels

3.5.l Relative standard deviation

3.6 Limit of determination

3.7 P1·ecision

3.7.l Repeatability

3.7.2 Independent laboratory validation

4.1 Materials and methods

4.2 Conclusion

4.2 .1 Reliability

4.2 .2 Deficiencies


ACTIVE SUBSTANCE RESIDUES IN AIR xxxx

xxxx

xxxx xxxx xxxx

xxxx

xxxx xxxx

xxxx

xxxx

4 APPLICANT'S SUMMARY AND CONCLUSION

xxxx

xxxx

Reliability indicator: XXXX

No

Page2

xxxx


Date

Mate1·ials and methods

Conclusion

R eliability

Acceptability

Remarks

Date


Conclusion

Reliability

Acceptability

Remarks


ACTIVE SUBSTANCE RESIDUES IN AIR xxxx




xxxx xxxx

xxxx

xxxx xxxx xxxx

COMMENTS FROM ...


Discuss additional relevant discrepancies refening to the (sub)heading numbers and to applicant's summaiy and conclusion. Discuss if deviating from view of rapporteur member state




Page 3


SUBSTANCE RESIDUES IN AIR



Detailed justification: According to the Technical Notes for Guidance on Data Requirements analytical methods must be submitted for the determination of active substance residues in environmental media, where relevant.

An analytical method for the detemlination of active substance residues in air must be submitted if the active substance is volatile or sprayed or its occwTence in air is othe1wise stated.

xxxx Since the occtmence ofDiatomaceous ea1th in air can be neglected it is justified not to submit an analytical method for the detennination of active substance residues in air.





Date xxxx

Evaluation of applicant's xxxx justification

Conclusion xxxx Remarks xxxx

Date COMMENTS FROM OTHER MEMBER STATE (specify)

Evaluation of applicant's Give date of comments submitted

justification Discuss if deviating from view of rapporteur member state

Conclusion

Remarks Discuss if deviating from view of rapporteur member state

Page I


SUBSTANCE RESIDUES IN WATER



Detailed justification: According to the Technical Notes for Guidance on Data Requirements analytical methods must be submitted for the determination of active substance residues in environmental media, where relevant.

xxxx In conclusion no analytical method is necessary for the detennination of active substance residues in water.







Remarks





Remarks

Page I

Section A4.2 Analytical Methods for Detection and Identification Annex Point IIA, IV 4.2 ANALYTICAL METHOD FOR THE DETERMINATION OF

ACTIVE SUBSTANCE RESIDUES IN ANIMAL AND HUMAN BODY FLUIDS AND TISSUES


Other existing data [ l Technica lly not feasible [ l Scientifically unjustified [ l Limited exposure [ l Other justification [X]

Detailed justification: According to the Teclmical Notes for Guidance on Data Requirements analytical methods for the determination of active substance residues in animal and human body fluids and tissues must be submitted where an active substance is classified as toxic or highly toxic. Since the active substance Diatomaceous earth is not classified as toxic or highly toxic no analytical method for its determination in animal and human body fluids and tissues must be submitted.




EVALUATION BY RAPPORTE UR MEMBE R STATE



COMMENTS FROM OTHER M EMBE R STATE (specify)




Remarks

Page I

Section A4.3 Analytical Methods for Detection and Identification BPD Annex Point IHA, ANALYTICAL METHOD FOR THE DETERMINATION OF

IV.I ACTIVE SUBSTANCE RESIDUES IN/ON FOOD OR FEEDSTUFFS


Other existing data I I Technically not feasible [ I Scientifically unjustified [ I Limited exposure I I Other justification [X)

Detailed justification: Analytical methods for the determination of active substance residues in/on food or feedstuffs are required if the active substance or the material treated with it is to be used in a manner which may cause contact with food or feedstuffs, or intended to be placed on, in or near soils in agricultural or horticultural use.

xxxx

xxxx

Undertaking of intended -data submission [ I






Remarks


Date Giw date of comments submitted



Remarks

Page 1




Silicon dioxide kiesekguhr or Diatomaceous Earth (DE)CAS N°:61790-53-2

EFFICACY

Final CAR CAR

November 2016

Silicon dioxide Kieselguhr PT 18 Final CAR November 2016

Section AS

Subsection (Annex Point)

5.1 Function (IIA5.1)

5.2 Organism(s) to be controlled and products, organisms 01· objects to be protected (IIA5.2)

5.2.1 Organism(s) to be controlled (IIA5.2)

5.2.2 Products, organisms 01· objects to be protected (IIA5.2)

5.3 Effects on target organisms, and likely concentration at which the active substance will be used (IIA5.3)

5.3.1 Effects on target organisms (IIA5.3)

5.3.2 Likely concentrations at which the A.S. will be used (IIA5.3)

PT18

Effectiveness against target organisms and intended uses

Insecticide

Acaricide

Target organisms include all kinds of crawling arthropods;

Common English name: Arthropods (Scientific name: Arthropoda)

1. Insects Clnsecta):

Black ant (Lasius niger)

Wood Louse (Porcelio scabe1)

Silverfish (Lepisma sacchmina)

Cat flea (Ctenocephalides felts)

2. Arachnids (Arachnida):

Poultry red mite (Dermanyssus gallinae)

All products are produced to protect poultry pens, private households, processing industry facilities, bakeries, glass houses etc.

Diatomaceous ea1th acts through absorption of the lipid layer covering arthropods' chitin protection, which then leads to desiccation and death of the target organism. By destructing the natural water ba1rier, the waxy layer of the cuticle and hence dismpting the functioning of the water preservation mechanism, diatomaceous earth interferes with physiological processes (Reillner, 2009).

Please refer also to the attached summa1·y table A5.3-1.

xxxx

Page 2

Official use only

xxxx

xxxx

xxxx


Section AS

5.4 Mode of action (including time delay) (IIA5.4)

5.4.1 Mode of action

5.4.2 Time delay

5.5 Field of use envisaged (IIA5.5)

MGOl: Disinfectants, general biocidal products

MG02: Preservatives

MG03: Pest control

MG04: Other biocidal products

Fwt her specification

5.6 Use1· (IIA5.6)

Industrial

Professional

General public


Contact action

Since target organisms have to dry out, time schedule depends on species and ambivalent conditions. Under European climatic conditions crawling insects generally are killed within 3 weeks. According to the test report the following contact time is required to achieve relevant or up to 100% efficacy:

xxxx

Product type 18: Insecticide and acaricide, indoor use

xxxx

preventive treatment and control

A thorough coverage of all surface areas with DE dust is essential because places where insects and mites retreat and hide are in the premises and cracks and crevices on constructions. DE can be applied with handheld blow & vacuum guns, resp. appropriate sandblasting guns connected to compressed air or with similar suitable dusting equipment.

A thorough coverage of all surface areas with DE dust is essential because places where insects and mites retreat and hide are in the premises and cracks and crevices on constructions. DE can be applied with handheld blow & vacuum guns, resp. appropriate sandblasting guns connected to compressed air or with similar suitable dusting equipment.

DE is sold in 0.5 - 11 bottles out of which it can be dusted directly . Hand operated dusters with 0.5 1 volume can be used for larger areas and DE is supplied in 2 kg bags for this purpose.

Page 3

xxxx


Section AS

5.7 Information on the occurrence or possible occurrence of the development of resistance and apprnpriate management strategies (IIA5.7)

5.7.1 Development of 1·esistance

5.7.2 Management strategies

5.8 Likely tonnage to be placed on the market per yea1· (IIA5.8)


Application rates under practical conditions produce 100% mo1tality. XXXX

Moreover InsectoSec has a bio-physical mode of action (desiccation) . The development of resistance has never been reported so far under practical conditions and can be regarded as very unlikely.

Application rates under practical conditions produce 100% mo1tality. XXXX

The development of resistance can therefore be regarded as very unlikely.

This infonnation is confidential and provided in the confidential pa1t of the dossier.

Page 4


Section AS

Date

Comments

Conclusion

Remarks

Date


Conclusion

Reliability

Acceptability

Remarks





xxxx xxxx xxxx xxxx xxxx xxxx

xxxx xxxx

xxxx

COMMENTS FROM ...


Discuss additional relevant discrepancies refening to the (sub)heading numbers and to applicant's summmy and conclusion. Discuss if deviating from view of rapporteur member state




Page 5

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final car - echadissemination.echa.europa.eu/.../1377-18/section_1-5.pdfa2 of dossier chemical...

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