Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
from 1972-05-25 to 1972-05-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP, similar to OECD TG 401

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Menthyl acetate
EC Number:
201-911-8
EC Name:
Menthyl acetate
Cas Number:
89-48-5
Molecular formula:
C12H22O2
IUPAC Name:
5-methyl-2-(propan-2-yl)cyclohexyl acetate

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
not reported
TEST ANIMALS
- Fasting period before study: 24 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no data
Doses:
5 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: clinical signs
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One female rat died on day 1 during the observation period of 14 days.
Clinical signs:
other: Morbidity noted in two rats soon after dosing followed by prostration and coma resulting in death of one female rat.
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was acutely non toxic to rats in an acute oral toxicity test with an LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

The acute oral toxicity of menthyl acetate was studied in a non-GLP test according to principles slightly deviating from those of current guidelines. 5 animals per sex were exposed to single oral dose of 5000 mg/kg bw. Animals were observed during a period of 14 days. Morbidity was noted in two rats soon after dosing followed by prostration and coma resulting in death of one female rat. The LD50 value was >5000 mg/kg bw.