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: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Duration of exposure:
24h
Doses:
4 and 8 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
7 100 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

females: no deaths amongst 5 animals @ 8000 mg/kg bw.

males: 3 deaths amongts 5 animals @ 8000 mg/kg bw. No deaths amongst 5 animals @ 4000 mg/kg bw.

There were no local cutaneous effects. No signs of systemic toxicity preceded the death of 3 males and no signs were evident in survivors. Time to death ranged from one to seven days. Gross pathologic findings included pink to red lungs, gas-filled stomach and intestines (in one) and enlarged gall bladders (in2).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 for male rabbits was 7100 mg/kg. For females, 8000 mg/kg did not produce deaths.
Executive summary:

The dermal LD50 for male rabbits was 7100 mg/kg bw. For females, the largest dose possible with the available sample, 8000 mg/kg bw did not produce death. There were no local cutaneous effects. No signs of systemic toxicity preceded the death of 3 males and no signs were evident in survivors. Time to death ranged from one to seven days. Gross pathologic findings included pink to red lungs, gas-filled stomach and intestines (in one) and enlarged gall bladders (in2).