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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
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 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
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:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Homosalate was administered orally at a single dose level of 5000 mg/kg bw.
Doses:
5 g/kg bw as single dose
No. of animals per sex per dose:
10 animals were used in this study
Control animals:
no
Details on study design:
The animals were observed for treatment-related effects and gross pathology was performed.
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.
Remarks on result:
other: only 1 out of ten animals was found dead during observation period
Mortality:
one animal was found dead during observation period (day 6)
Clinical signs:
other: Animal that died showed signs of diarrhea
Gross pathology:
Necropsy revealed 4/10 animals were normal; yellow areas in the intestines of 1/10 animals; mottled liver in 1/10 animals; dark lungs in 1/10 animals; dark areas in the lungs in 5/10 animals; dark spleen in 1/10 animals.

Applicant's summary and conclusion

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

In this study 10 rats 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.

One out of 10 rats died on day 6 of the observation period 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.

Clinical sign observed were diarrhea. 4 out of 10 animals showed no effects upon necropsy. Effects seen in 6 animals were yellow areas in the intestines of 1/10 animals; mottled liver in 1/10 animals; dark lungs in 1/10 animals; dark areas in the lungs in 5/10 animals; dark spleen in 1/10 animals.