Registration Dossier

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: Brief report, however giving sufficient experimental detail. Similar to guideline test methods.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1984
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
No guideline available at the time. Conduct similar to subsequently developed guidelines.
GLP compliance:
no
Test type:
other: limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Galliumarsenid
no details stated

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Normal food and drinking water ad libitum. Room temperature 20°-24°, relative humidity 40-65%. Animal age at start of test 8-10 weeks. Average body weight 185.5 +- 18g.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: slighly wetted with distilled water
Details on dermal exposure:
Fixed for 24h with a gauze pad under an elastic bandage.
Duration of exposure:
24 h
Doses:
From the report it appears that several doses were tested. However, only the limit dose of 10000 mg/kg bw is actually stated.
No. of animals per sex per dose:
not stated
Control animals:
not specified
Details on study design:
Obeservation period 14 days.
Statistics:
not reported

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
general behaviour appeared unaffected
Body weight:
not reported
Gross pathology:
no substance related changes in organs observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

A single dermal dosage of 10000 mg GaAs/kg bw was applied to female Wistar rats. The test article was slightly wetted with distilled water and applied in an occlusive way. The animals were fixed for 24h with a gauze pad under an elastic bandage. The rats were kept at a room temperature of 20°-24°, a relative humidity of 40-65% and with free access to food and water. Animal age at start of test was 8-10 weeks and the average body weight 185.5 +- 18g. The observation period after application was 14 days. No substance related changes were observed in the animals. Study design similar to guideline test method.

LD50 rat, dermal > 10000mg GaAs/kg bw.