Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
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:
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:
Animal that died showed signs of diarrhea
Body weight:
no data
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.