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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Homosalate
EC Number:
204-260-8
EC Name:
Homosalate
Cas Number:
118-56-9
Molecular formula:
C16H22O3
IUPAC Name:
3,3,5-trimethylcyclohexyl 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:
other: No clinical signs were observed.
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.