Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Unpublished report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Age at study initiation: 12 weeks of age - Weight at study initiation: 2.07-2.69 kg- Fasting period before study:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Single dermal application of 2000 mg TNPP/kg body weight for 24 hours, using a determined density of 1.1 gm/mL.TEST SITE- Area of exposure: The test substance was introduced under gauze patches, two single layers thick, and applied directly to the skin of the body surface.- % coverage: 10%- Type of wrap if used: Animals were immobilized and the patches were secured in place by wrapping the entire trunk of the animal with an impervious bandage. Test sites were secured to prevent the animals from ingesting the test substance. REMOVAL OF TEST SUBSTANCE- Washing (if done): At the completion of the exposure period, the wrapping was removed and the skin was gently wiped to remove any test substance still remaining.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
other: needed for data submission
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical examination was made at least once a day- Necropsy of survivors performed: yes, gross necropsy was performed on all animals.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
No overt signs of systemic toxicity were evident during the course of the study. No erythema or edema was observed at any of the test sites.
Body weight:
Following the 24-hour exposure, all animals (with the exception of one, which weight loss was : 0.02 kg) gained weight during the 14-day post-treatment observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: expert judgment
Conclusions:
Based on the absence of mortality, the LD50 was determined to be greater than 2000 mg/Kg.
Executive summary:

Based on the absence of mortality, the LD50 was determined to be greater than 2000 mg/Kg.