Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
August-December 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline study; not GLP-compliant
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Principles of method if other than guideline:
four animals used
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: amber liquid
Details on test material:
- Test Material: C-1054
- Description: Amber liquid
- Date Received: August 7, 19B6
- Storage: Temperature - monitored room (60-85°F)
- Density: 1.2208 g/ml

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
no data
Duration of exposure:
24 hours
Doses:
Dose level: 5000 mg/kg
Dose volume: 4.1 ml/kg
No. of animals per sex per dose:
4 animals
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
No clinical signs noted
Body weight:
No changes on body weights observed
Gross pathology:
No pathological findings noted

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 on rabbits was found to be > 5000 mg/kg.
Executive summary:

The LD50 was performed similar or equal to OECD 402 using rabbits; one dose level was tested and four animals used. The acute dermal LD50 was found to be > 5000 mg/kg.