i..ji 0 ' f i reclassification of materials listed as transportation hcalth hazards ---...

Report No. TES-20-73-3

RECLASSIFICATION OF MATERIALS LISTED ASTRANSPORTATION HEALTH HAZARDS SUPPLEMENT I

K. C. BackI

A. A. Thomas

J. D. MacEwen

Best Avaab!e CopylSEPTEMBER 1913FINAL REPORT ,

DISTFRIBUTION STATEMENTA 2

Approved fsr public iAcase; cDistribution Un dimi~ed

Document is available to the public through theNational Technical Information Service,

Springfield, Virginia 22151

DEPARTMENT OF TRANSPaRTATIONOFFICE OF THE ASSISTANT SECRETARY i.

FOR ENVIRONMENT, SAFETY AND CONSUMER AFFAIRSOffice Of Hazardous Materials

Washington, D.C. 20590 3-78 08 0 05

o11 0(• 0r [O " ..

This document is disseminated under the sponsorshipof the Department of Transportation in the interest ofexchange. The United States Government assumes noliability for its contents or use thereof.

The contents of this report reflect the views of theauthors who were responsible for the facts andaccuracy of the data presented herein. The con-tents do not necessarily reflect the official views orpolicy of the Department of Transportation. Thisreport does not constitute a standard, specificationor regulation.

• • .. • , •• •,,,--

TECHNICAL REPORT STANDARD TITLE PAGE

1. Report No. 2. Government Accession No. 3. Recipient's Catalog No.

'Ti-TE3-20-73-3

4. Title and Subtitle 5. Report Date

RECLASSIFICATION OF MATERIALS LISTED AS September 1973TRANSPORTATION HEALTH HAZARDS --- SUPPLEMENT 6. Performing Organization Code

I 6570th AMRL/TH7. Author(*) ý8. Performing Organization Report No.

"" . C. Back, A. A. Thomas and J. D. MacEwen* AMRL-TR-78-68

9 . Per'Irnming'Organizotion Name and Address 10. Work Unit No.6y5C((th erospace Medical Research Laboratory(AFSC) dright-Patterson Air Force Base, Ohio 01 Contract or Grant No.

r Toxc Hazards Research Unit, UnIversi y DOT-AS-10028/2of ilfornia--a contractor to the Air Force) 13.T-yS-lof0epr adPeid2 arr3.Type of Report and Period Covered

12. Sponsoring Agency Name and AddressOffice of Hazardous Materials, Office of the FinalAssistant Secretary for Environment, Safety July 1972-June 1973and Consumer Affairs, Department of Trans- 14. Sponsoring Agency Codeportation, Iashington, D. C. 20590 TE.S-20

15. Supplementary Notes

16. Abstract

This final report ona contract between the Department of Tn-portation and the United States Air Force Toxib Hazards Laboratcry Sup-lements the acute toxicity data reported in TSA-20-72-3. In the pre-vious report the toxicity of several compounds of interest to theDepartment of Transportation was discussed. This was done in the llghtof a reexamination of existing data or the determination of acutetoxicity data on those compounds where no previous data existed. Theinformation so gathered was used to help reclassify thence compouncJ3into categories which may help to define shipping and handling requIre-ments concomitant with the hazard associated with each compound. Theclassifications assigned are not official regulatory classiflcation3and are presented for technical information only.

Seven new compounds were examined in this same light to provideadditional in ormation to the Department of Transportation. Thesecompounds are as follows: mixed cresols, allyl isothiocyanate, methylisothiocynate, methyl isocyanate, ortho-nitroaniline, ethyl chloro-acetate and phenyl isocyanate.

17. Key Words 18. Distribution Statement

Toxicity, hazard, classification, IDocument is available to the publ.icdermal toxicity inhalation through the National Technicaltoxicity, oral toxicity, poisn, Information Service, Springfield,transportation, LC5 0, LD5 0 , PPM, Virginia 221:,lmg/M __

19. Security Classif. (of this report) 20. Security Classif. (of this page) 21. 0a. of Pages 22. Prices

Unclassified Unclassified .9

Form DOT F 1700.7 (8.6.9)

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Reclassification of Materials Listed as

Transportation Hcalth Hazards --- Supplement I

This final report on a contract between the Department of Transportationand the United States Air Force Toxic Hazards Laboratory supplements the acutetoxicity data reported in TSA-20-72-3. In the previous report the toxicity ofseveral compounds of interest to the Department of Transportation was discussel.This was done in the light of a reexamination of existing data or the determinationof acute toxicity data on those compounds where no previous data existed. Theinformation so gathered was used to help reclassify these compounds into categorieswhich may help to define shipping and handling requirements concomitant with thehazard associated with each compound. The classifications assigned are notofficial regulatory classifications and are presented for technical informationonly.

Seven new compounds were examined in this same light to provide additionalinformation to the Department of Transportation. These compounds are listedbelow:

1. mixed cresols2. allyl isothiocyanate3. methyl isothiocyanate4. methyl isocyanate5. ortho-nitroaniline6. ethyl chloroacetate7. phenyl isocyanate

The materials were classified as requested by the Department ofTransportation according the "Extremely Toxic" and "Highly Toxic" criteriashown in the Second Advance Notice of Proposed Rule Making Docket No. HM-51(36 F. R. 2934), published February 12, 1971.

A third classification of "Toxic" was used for some of the materialswhich did not fall in the above "Extremely Toxic" or "Highly Toxic" categories,but for which adequate data was available for classification. We were concernedthat the uses of the proposed revised commodity list would misinterpret the lackof classification as meaning nontoxic.

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Most of these materials are toxic and, therefore, we have classified them assuch for consideration by the Department of Transportation.

The "Toxic" classification is a direct downward classification of the acuteLD6 and LCw levels used in the "Extremely Toxic" and "Toxic" levels, mentionedpreviously. It corresponds to the "Toxic Substances" category found in Section191. 1, Title 21 - Food and Drug, CFR, Revised as of January 1, 1970. Theclassification system used is shown below:

ExtremelyToxic Highly Toxic Toxic

Inhalation, 1 Hour 500 mg/rn >500-2000 mg/in 3 . >2000-200,000 mg/rmLC_ or less (>50-200ppm) (>200-20,000 ppm)

(50 ppm orless)

Oral, 14-Day Single 5 mg/Kg >5-50 mg/Kg >50-5000 mg/KgDose LCG, or less

Skin Absorption 20 mg/Kg >20-200 mg/Kg >200-20,000 mg/Kg(Dermal) LD40 orless

Since the new classifications were based solely on acute toxicity, allforms of a material (concentrates, solutions, mixtures, etc. ) have been assignedto the same toxicity categories regardless of concentration of the active ingre-dients. No consideration was given to hazard potential of the materials reclas-*sified. For purposes of uniformity all inhalation toxicity data was converted tomg/i 3 if given in other units of measurement. These values may be converte ito parts per million by use of the following formula:

ppm = 24.50 x mg/tn 3

mol. wt.

Conversion of units from mg/rn to ppm may, in certain instances change theclassification in which borderline compounds may fall. In those instanceswhere this happens the mg/rn unit should take precedence.

All seven compounds listed previously were administered to rabbits todetermine skin absorption LD,' values, and three of the seven compounds (allylisothiocyanate, methyl isothiocyanate and methyl isocyanate) were administeredorally to both rats and mice to determine the LD,0 's in each of these species.These studies were designed to define the acute toxic response of the subjectcompound resulting from single accidental exposure and do not define the potentialtotal hazard of carcinogenic risk or inhibition of performance of emergency dutiesincluding self rescue.

2

For the determination of oral toxicity, l foliowing CedlO,!s w ,, r• ti:

Male CFE rats (200-300 grams) and ma~e CI-1 mice (20-30 grams) : .used in this study.

The compounds were given as a suspension in corn oil and the juspCnsionvwere kept in a turbulent state while in use. Glass syringes with special oraldosing needles were used to administer the compounds to the rodlcrts. Theexperimental animals were fasted overnight prior to administration of the oraldose. This allowed for more uniform absorption, since the amount of food inthe stomach varies greatly from animal to animal in the unfasted condition.The injected volumes of test compounds for the rodents were approximately0. 01 m!/gm. This resulted in the ,verage mouse receiving a volume of 0.25 ml,and the average rat a volume of 2. 5 ml. Both mice and rats were weighed indi-vidually at the time of dosing to determine the proper dose volume.

Range-finding doses were given for each compound. These consistedof intubating five rats and five mice each at three dose levels estimated fromavailable evidence in the literature, or if information was not available, doselevels of 5 mg/kg, 50 mg/kg and 500 mg/kg were used. Results of the range-finding tests served to determine whether doses needed to be higher or lower.After finding the proper range, geometrically spaced doses were administare'lto determine the actual LD.0. Five rats and five mice were dosed at each level,and the LD., %,ith its 95%0 confidence limits was calculated using the movingaverage interpolation method.

Deaths which occurred during the 14 days immediately following theadministration of the single dose were included in the final mortality tally.

For the dermal absorption toxicity determinations, female albino NewZealand rabbits weighing approximately 5 pounds were used as the experimentalanimals. All rabbits were clipped as closely as possible with an Oster clipperhaving surgical blades and a vacuum attachment. The back of the rabbits• andthe sides down to about half way to the stomach area were clipped from thesaddle area of the shoulders to the top of the rear leg area.

The animals were individually weighed to determine the proper dosevolume. The measured volume of the liquid material was then applied undilutedto the back- of the rabbit and was divided as equally as possible between the twosides of the back. If the volume was sufficiently great, the dose was kept inplace by applying 8-ply gauze patches over the liquid on each side of the back.A patch of latex rubber dental dam or vinyl plastic, whichever was most com-patible with the compound being tested, was then applied over the entire backarea where clipped, and elastoplast tape was used to wrap the entire midsectionof the rabbit to keep the gauze in place. Specially designed rabbit restraining

3

harnesses were fitted to each rabbit at the time of treatment. These harnessesrestricted undesirable movement of the rabbits, i.e., prevented them fromchewing on the taped area. The harnesses did, however, allow the rabbitscomplete freedom to eat and drink during the 24-hour restraining period.

All compounds were applied undiluted. The single solid material(ortho-nitroaniline) was applied in coarse powder form held in place withgauze patches and a rubber dental dam.

The test compounds remained in contact with the rabbit's skin for 24hours. After this period of time, the gauze tape and harness were removed.The rabbits were observed for signs of toxicity or death during the 14 daysimmediately following dosing. The classification of these compounds is shownin Table I. Data sheets listing LDR0 values and justification for each classifica-tion are attached in Appendix A. Information concerning the source, lot numberand purity or grade of the individual compounds is given in Appendix B.

Although classification of irritation effects of those compounds was nota part of this study, the very potent lacrimation induction by several of thecompounds, most notably the isocyanates, was impossible to overlook. Theseproperties would certainly have to be considered when establishing safety reg-ulations for the handling and storage of these compounds.

TABLE 1. CLASSIFICATION OF COMPOUNDS BASED ONACUTE TOXICITY TESTS

Code Toxicity

Number Name Classification

103 ortho-nitroaniline Toxic

246 cresols, mixed Toxic

249 alljl isothiocyanate Highly Toxic

250 ethyl chloroacetate Toxic

251 methyl isothiocyanate Highly Toxic

252 methyl isocyanate Toxic

253 phenyl isocyanate Toxic

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II

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jAPPENDIX A

4.

DATA SHEETS

I

* �- . - -7. j

TOXICITY DATA. SHEET

COMPOUND: ORTHO-NITROANILINE CODE: 103t

CLASSIFICATION: T 0 X I C

INHALATION TOXICITY ORAL TOXICITY

SPECIES CONC. SYS. ** REF. SPECIES DOSE*** SYS. ** REF.

Man Man

Rat Rat 3564 LD,5

Mouse Mouse 1288 LD50

Dog Dog

Monkey Monkey

Other Cat

Guinea Pig

Other

OTHER ROUTES OF ADMINISTRATION

SPECIES ROUTE DOSE*** SYS. ** REF.

1. Rabbit Dermal 20,000 Nonlethal2.3.4.5.

• Concentration in mg/M 3

** System for expression of toxicity***Dose in mg/Kg

Revised 1973 A-1 •,

/"----------- "

JUSTIFICATION:

Data generated under contract between the Department of Transportation ani.. ,-

United States Air .Force Toxic Hazards Laborato'ry.

Rat 14-Day Oral LD5 0 = 3564 mg/kg95% Confidence Limits (2590-4910)

Mouse 14-Day Oral LD50 = 1288 mg/kg95%0 Confidence Limits (1131-1467

Rabbit 14-Day tests after 24 hours skin contact of 20, 000 r.: ..were nonfatal indicating poor absorption of orthc-nitroaniii.through the skin. Exposure levels above the value are meaning--

REF. The oral toxicity data fall in the "Toxic" category.

IA1

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TOXICITY DATA SIIILBT

COMPOUND: CRESOLS (Mixed ortho, mcta and para forms) CO')1:: 246t



SPECIES CONC. * SYS. ** REF. SPECIES DOS E* SYS. ** REF.

Man Man

Rat Rat 1454 LD50

Mouse Mouse 861 LDs0

Dog Dog

Monkey Monkey

Other Cat

Guinea Pig

Other


SPECIES ROUTE DOSEI:** SYS. ':s ;` REF.

1. Rabbit Dermal 1782 mg/kg2.3.4.5.

.6.

SConcentration in mg/M 3

* System for expression of toxicity***Dose in Kg

tRevised 11-

JUSTI F ICATION: 246

Data generated under contract between the Department of Transportation and the

United States Air Force Toxic Hazards Laborato'ry.

Rat 14-Day Oral LD50 = 1454 mg/kg95%o Confidence Limits (563-3550)

Mouse 14-Day Oral LD5 0 = 561 mg/kg95%7 Confidence Limits (456-677)

Rabbit 14-Day Dermal LD50 = 1782 mg/kg(24-Hour Skin Contact) 95%o Confidence Limits (959-3336)

Data fall in the "Toxic" category.

A

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TOXICITY DATA SIHEET

* COMPOUND: ALLYL ISOTIIIOCYANATE CODE: 249

CLASSIFICATION: H I G H L Y T 0 X I C

INHALATION TOXICITY ORAL TOXICITYSPECIES CONC. * SYS. ** REF. SPECIES DOSE*** SYS. ** REJ.

Man Man

Rat Rat 488 LD--

Mouse "_Mouse 308 LD5 0

Dog _Dog

Monkey Monkey

Other Cat

Guinea Pig

Other

OTHER ROUTES OF ADMINISTRATIONSPECIES ROUTE DOSE*** SYS. * REF.

1. Rabbit Dermal 88 LD,-2. !

3.4.

Concentration in mg/M 3

System for expression of toxicity***Dose In mg/Kg A-5

JUSTIFICATION: 249

Data generated under Contract between the Department of Transportation and the

United States Air Force Toxic Hazards Laboratory.

Rat 14-Day Oral LD5 0 = 488 mg/kg95%o Confidence Limits (235-1010)

Mouse 14-Day Oral LD5 0 = 308 mg/kg95%0 Confidence Limits (194-688)

Rabbit 14-Day Dermal LD5 0 = 88 mg/kg(24-Hour Skin Contact) (no confidence limits)

Data fall in "Toxic" category by oral exposure and in the "Highly Toxic" classification

by the dermal route. Since transportation accidents may readily produce dermal

exposures allyl isothiocyanate is classified as "Highly Toxic."

A- 6

TOXICITY DATA SHEET

COMPOUND: ETHYL CHLOROACETATE CODE: 250



SPECIES CONC. * SYS. ** REF. SPECIES DOSE*** SYS. ** REF.

Man Man

Rat Rat

Mouse Mouse

Dog Dog

Monkey Monkey

Other Cat

Guinea Pig

Other



1. Rabbit Dermal 255 LD502.3.4.5.

.6.

* Concentration inmg/M3** System for expression of toxicity***Dose in mg/Kg A-.

LI

JUSTIFICATION: 250

Data generatcd under contract between the Department of Transportation and the


Rabbit 14-Day Dermal LD5 0 = 255 mg/kg(24-1-Hour Skin Contact) 95%.Confidence Limits (118-246)

Data fall in the "Toxic" category.

A-8

TOXICITY DATA SHEET

COMPOUND: METHYL ISOTHIOCYANATE CODE: 251

CLASSIFICATION: H I G H L Y T 0 X I C

INHALATION TOXICITY ORAL TOXICITYSPECIES CONC. * SYS. ** REF. SPECIES DOSE*** SYS *. REF.

Man Man

Rat tRat 218 LD50

Mouse Mouse 106 LD50

Dog Dog

Monkey Monkey

Other _ Cat

Guinea Pig

Other



1 1. Rabbit Dermal 33 ,LDS 02.3.4.5.6.

Concentration in mg/M 3

System for expression of toxicity•**Dose in mg/Kg A-9

JUSTIFICATION: 251

Data generated under contract between the Department of Transportation and the


Rat 14-Day Oral LD5 0 - 218 mg/kg95% Confidence Limits (108-443)

Mouse 14-Day Oral LD5 0 = i06 mg/kg95% Confidence Limits (38-300)

Rabbit 14-Day Dermal LD5 0 = 33 mg/kg(24-Hour Skin Contact) 95%o Confidence Limits (18-64)

Data fall in the "Toxic" category by oral exposure and in the "Highly Toxic"

category by the dermal route. Since transportation accidents may readily produce

dermal exposures in ethyl isothiocyanate is classified as "Highly Toxic."

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TOXICITY DATA SHEET

COMPOUND: METHYL ISOCYANATE CODE: 252

CLASSIFICATION: T 0 X i C


SPECIES CONC. * SYS. ** REF. SPECIES DOSE*** SYS. ** RI'F.

Man Man

Rat Rat 138 LD5o

Mouse Mouse 123 LD5 0

Dog Dog

Monkey Monkey

Other Cat

Guinea Pig

Other



1. Rabbit Dermal 1796 LD502.3.4.5.

* Concentration in mg/M 3

** System for expression of toxicity***Dose in mg/Kg A-U

A- i

JUSTIFICATION: 252

-" Data generated under contract between the Department of Transportation and the


Rat 14-Day Oral LD50 = 138 mg/kg95•o Confidence Limits (55-343)

Mouse 14-Day Oral LDs0 = 123 mg/kg95•o Confidence Limits (78-195)

Rabbit 14-Day Dermal LD$o= 1796 mg/kg(24-Hour Skin Contact) 95•o Confidence Limits (945-3411)

Data all fall in the '.'Toxic" category.

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TOXICITY DATA _SIIEE-T

*COMPOUND: PHENYL ISOCYANATE CODE: 253



SPECIES CONC.* SYS." REF. SPE'CIES DOSE*** SYS'" REF.

Man ____ ___ ____Man____ ___

Rat ____Rat____ ___

Mouse ____ Mouse___

Dog ____ ___ ____Dog ___

Monkey _____ ___ Monkey

Other _ _ _ _ _ _ __Cat _ _

G uinea Pig __________________ __________________

Other____ _ __


*SPECIES ROUTE DOSE*** SYS. ** REF.

1. Rabbit Dermal 7127 LD502.-3.4.

*Concentration in mg/M 3

**System for expression of toxicity***Dose inmg/Kg A1

A-13

JUSTIFICATION: 253

Data generated under contract between the Department of Transportation and

the United States Air Force Toxic Hazards Laboratory

Rabbit 14-Day Dermal LD50 = 7127 mg/kg

(24-Hour Skin Contact) 95% Confidence Limits (3744-13, 535)

Data fall in "Toxic" category.

A-14

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''-IAPPENDIX B

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-4- . -'- . . .. - .426

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Chemical Statement of Purity Source Numbei

Cresol, mixed National Formulary j.T. Baker 365%-

Allyl Isothiocyanate BP 150-1520 C MCB* 5106-

Methyl !sothiocyanate MP 35- 360 C MCB lO02O

Methyl Isocyan~ate BP 37- 390 C MCB 9641-

Phenyl Isocyanate BP 60-620 C/20 mm MCB 60S88

Ortho-Nitroaniline MP 71-720C MCB 2786,

Ethyl Chioroacetate BP 142- 1440 C MCB 5635:ý

*Mathe son, Coleman & Bell

B-1

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i..ji 0 ' f i reclassification of materials listed as transportation hcalth hazards ---...

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