Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
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.