Registration Dossier

Administrative data

Description of key information

Oral: LD50 > 5000 mg/kg body weight leading to not classification according to CLP
Dermal: LD50 > 5000 mg/kg body weight leading to not classification according to CLP
Inhalation: no information available

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals 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
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
Preliminary study:
no data
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:
Morbidity noted in two rats soon after dosing followed by prostration and coma resulting in death of one female rat.
Body weight:
no data
Gross pathology:
no data
Other findings:
no data
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Only one key study is available. This study is similar to OECD TG 401.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP, similar to OECD TG 402
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 abraded rabbits
Principles of method if other than guideline:
Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
5 g/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
-3 animals dosed on intact and 3 on abraded skin.
Statistics:
no data
Preliminary study:
no data
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
Mild erythema followed by slight drying and cracking of skin.
Body weight:
no data
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was acutely not toxic to rabbits in an acute dermal toxicity test with a LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

The acute dermal toxicity of menthyl acetate was studied in a non-GLP test according to the method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961. Group of six animals (3 intact and 3 abraded skin) were exposed to single dermal dose of 5 g/kg bw. Animals were observed during a period of 14 days. No mortality was reported within observation period. The LD50 value was >5 g/kg bw. As symptoms, mild erythema followed by slight drying and cracking of skin was reported.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Only one study is available in whole database for the acute dermal toxicity. This study is similar to OECD TG 402.

Additional information

- oral toxicity:

The substance menthyl acetate is not acutely toxic to rats in an acute oral toxicity study and the oral LD50 value is above 5000 mg/kg body weight (Moldovan 1972).

- dermal toxicity:

The substance menthyl acetate is not acutely toxic in an acute dermal toxicity study in rabbits with a dermal LD50 value above 5000 mg/kg body weight (Moldovan 1972).

Dermal and oral routes of exposure are considered to be the most likely routes of human exposure to this fragrance substance. Overall, the registration item exhibits no acute toxicity.


Justification for selection of acute toxicity – oral endpoint
A reliable with restrictions key study similar to OECD TG 401.

Justification for selection of acute toxicity – dermal endpoint
A reliable with restrictions key study similar to OECD TG 402.

Justification for classification or non-classification

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity of menthyl acetate, the results from reliable with restrictions study are above the threshold value given in the CLP Regulation. Therefore menthyl acetate does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity, menthyl acetate does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- inhalation toxicity:

No inhalation studies are available and due to exposure considerations the conduct of studies and the classification and labelling for this endpoint is deemed not to be necessary.