1,2-Benzenediamine, ar-methyl-, reaction products with propylene oxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Diaminotoluene, propoxylated

EC Number:

918-139-9

Cas Number:

1228577-90-9

Molecular formula:

(C3H6O)n (C3H6O)n (C3H6O)n (C3H6O)n C7H10N2 sum of n: >1 - <8.5

IUPAC Name:

1,2-Diaminotoluene, propoxylated

Details on test material:

- Name of test material (as cited in study report): O-Diaminotoluene, propoxylated
- Physical state: red, extremely viscous liquid
- Molecular weight: Mn = 340 g/mole
- Composition of test material, percentage of components: Propylene oxide (100%)
- Lot/batch No.: QC 28080735
- Storage condition of test material: room temperature in the dark, over silica gel

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS:
- Source: Bantin & Kingman, Hull, UK
- Age: 8 to 12 weeks
- Weight at study initiation: > 200 g
- Group size: individual housing
- Controls:

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

ADMINISTRATION:
- Area covered: approx 10% of total body surface
- Occlusion: semi occluded with self-adhesive bandage
- Vehicle: undiluted
- Concentration in vehicle: undiluted
- Total volume applied: not specified
- Doses: single dose: 2000 mg/kg bw.
- Removal of test substance:

Doses:

single dose: 2000 mg/kg b.w.

No. of animals per sex per dose:

5

Details on study design:

EXAMINATIONS:
During and after exposure, animals were observed for signs of toxicity 30 min, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. AT the end of the study, all animals were killed and subject to gross necropsy (external examination, opening of the abdominal and thoracic cavities.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: (nominal)

Mortality:

There were no deaths during the study.

Clinical signs:

other: No signs of systemic toxicity.

Gross pathology:

No abnormalities noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal does (LD50) was found to be greater than 2000 mg/kg bw.