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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study summary, no GLP, deviations compared to OECD 402

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: 09-I2-28Purity: not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: 2311 - 2812 grams- Diet (e.g. ad libitum): ad libitum - Water (e.g. ad libitum): ad libitumNo additional dataENVIRONMENTAL CONDITIONSNo information provided

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE- Area of exposure: the back- % coverage: - Type of wrap if used: gauze bandages and Saran WrapREMOVAL OF TEST SUBSTANCE- Washing (if done): tepid water- Time after start of exposure: 24 hoursTEST MATERIAL- Amount(s) applied (volume or weight with unit): 2000 mg/kg- Concentration (if solution): undiluted- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 male and 2 female per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: not indicated- Necropsy of survivors performed: - Other examinations performed: body weight,organ weights
Statistics:
None stated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
No information provided
Body weight:
Normal body weight gains was observed.
Gross pathology:
No information provided

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.
Executive summary:

4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.

The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.