A mixture of: 3,5-dimethylthio-2,4-toluenediamine; 3,5-dimethylthio-2,6-toluenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

EEC B.1, EPA 560/6-83-001

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: 3,5-dimethylthio-2,4-toluenediamine; 3,5-dimethylthio-2,6-toluenediamine

EC Number:

403-240-8

EC Name:

A mixture of: 3,5-dimethylthio-2,4-toluenediamine; 3,5-dimethylthio-2,6-toluenediamine

Cas Number:

106264-79-3

Molecular formula:

C9H14N2S2

IUPAC Name:

reaction mass of: 3,5-dimethylthio-2,4-toluenediamine 3,5-dimethylthio-2,6-toluenediamine

Test material form:

other: clear liquid

Details on test material:

purity: 95.14 % diamines

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

- Range-finding test: 500, 3200 and 5000 mg/kg
- Main study: 1000, 1250, 1600 and 2500 mg/kg

No. of animals per sex per dose:

- Range finding test: 3 groups of 2 animals (1 M, 1 F)
- Main study: 4 groups of 10 fasted rats (5M, 5F)

Control animals:

no

Results and discussion

Preliminary study:

A dose range finding study was performed using 3 groups of 2 animals (1 M, 1 F). Animals were administered test compound at 500, 3200 and 5000 mg/kg by oral gavage. None of the rats died at 500 mg/kg. All of the rats died at the other two dose groups. In the definitive study, 4 groups of 10 fasted rats (5M, 5F) were orally administered the test article at 1000, 1250, 1600 and 2500 mg/kg.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 515 mg/kg bw

95% CL:

>= 960 - <= 2 048

Mortality:

Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1250 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1600 mg/kg bw; Number of animals: 5; Number of deaths: 4
Male: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 4
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 1250 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 1600 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 5

Clinical signs:

other: Signs of toxicity related to dose levels: A dose range finding study was performed using 3 groups of 2 animals (1M, 1F). Animals were administered test compound at 500, 3200 and 5000 mg/kg by oral gavage. None of the rats died at 500 mg/kg. All of the ra

Gross pathology:

Effects on organs:
a) 1000, 1250 and 1600 dose levels

Necropsy of animals dying in study revealed hemorrhagic stomach lesions, discolored lungs, hydrothorax, discolored fluid-filled bladders

b) 2500 mg/kg dose level

No visible lesions observed in any animal at terminal necropsy

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity LD50 was found to be 1515 mg/kg bw for males/females. In conclusion, the test substance has to be classified Toxicity Category IV based on the results of this test.

Executive summary:

The acute oral toxicity on rats was determined in a GLP study according to OECD guideline 401 and EU test method B.1. Vehicle was corn oil. A dose range finding study was performed using 3 groups of 2 animals (1 M, 1 F). Animals were administered test compound at 500, 3200 and 5000 mg/kg by oral gavage. None of the rats died at 500 mg/kg. All of the rats died at the other two dose groups. In the definitive study, 4 groups of 10 fasted rats (5M, 5F) were orally administered the test article at 1000, 1250, 1600 and 2500 mg/kg.

Signs observed were decreased activity, ptosis, piloerection, decreased muscle tone, abnormal gait, abnormal stance, poor grooming, diarrhea, chromodacryorrhea and prostration. One of 10 died at 1000 mg/kg, 2110 at 1250 mg/kg, 7110 at 1600 mg/kg and 9/10 at 2500 mg/kg. Necropsy of dead animals revealed hemorrhagic lesions in the stomach, discolored intestines, discolored lungs, hydrothorax and discolored fluid filled bladders.

The acute oral toxicity LD50 was found to be 1515 mg/kg bw for males/females. In conclusion, the test substance has to be classified Toxicity Category IV based on the results of this test.