Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: pre OECD and pre-GLP study with limited documentation but fulfilling basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Sample marking: 77-479
Chemical name: Homomenthyl salicylate

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw applied
No. of animals per sex per dose:
10 animals
Control animals:
no
Statistics:
not required

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occured
Clinical signs:
No clinical signs were observed.
Body weight:
no data
Gross pathology:
Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.
Other findings:
Skin redness slight in 4/10 and moderate in 6/10 animals
Skin edema slight in 7/10 and moderate in 3/10 animals

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (dermal., rabbit): > 5000 mg/kg bw
Executive summary:

In this study 10 rabbits per dose were used (only one dose applied being 5000 mg/kg and therefore no further doses were applied). Animals were observed for mortality and/or systemic effects. Gross necropsy was performed on all animals.

All rabbits survived the study until end and thus the LD50 was found being > 5000 mg/kg. No further doses were consequently applied and the study may be considered as limit test accordingly.

No clinical sign observed. Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.

Slight skin redness was observed in 4 and moderate redness in 6 animals whereas in 7 animals slight edema were noted and moderate edemas in thee remainder.