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Description of key information

No studies are available for L-menthyl acetate. Reliable data are available with the structural analogue menthyl acetate (CAS 89 -48 -5).

Oral (RA CAS 89 -48 -5): LD50 > 5000 mg/kg body weight leading to non-classification according to CLP
Dermal (RA CAS 89 -48 -5): LD50 > 5000 mg/kg body weight leading to non-classification according to CLP
Inhalation: no information available

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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
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 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
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no data
Doses:
5000 mg/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
Key result
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
Interpretation of results:
GHS criteria not met
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:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

Please refer to the attached read across justification in section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Preliminary study:
no data
Key result
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
Interpretation of results:
GHS criteria not met
Conclusions:
L-menthyl acetate is estimated to be acutely non toxic to rats with an LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

One study is available from structural analogue menthyl acetate CAS 89 -48 -5. The LD50 for L-methyl acetate was estimated to be greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on structural similarities (refer to read across justification for further details). The selected study is thus sufficient to fulfill the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

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
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 or test system 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:
5000 mg/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
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
other: Mild erythema followed by slight drying and cracking of skin.
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
GHS criteria not met
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 a 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:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

Please refer to the attached read across justification in section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 abraded rabbits
Preliminary study:
no data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
other: Mild erythema followed by slight drying and cracking of skin.
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
L-menthyl acetate is estimated to be acutely non toxic to rats with an LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

One study is available from structural analogue methyl acetate CAS 89 -48 -5. The LD50 for L-methyl acetate was estimated to be greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on structural similarities (refer to read across justification for further details). The selected study is thus sufficient to fulfill the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

Additional information

No studies are available with L-menthyl acetate regarding acute toxicity. Reliable data are available with the structural analogue menthyl acetate (CAS 89-48-5). The source substance menthyl acetate (CAS 89-48-5) is a racemic mixture of L-menthyl acetate and D-menthyl acetate thus containing the target substance. The presence of D-menthyl acetate in the mixture is not considered to have an impact on the assessment of the mammalian toxicity of the target substance. For detailed information refer to the analgogue justification.

Oral toxicity:

The source 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 (1972).

Dermal toxicity:

The source 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 (1972).

Dermal and oral routes of exposure are considered to be the most likely routes of human exposure to this fragrance substance. Overall, the substance is also considered to exhibit no acute toxicity.


Justification for classification or non-classification

Oral toxicity:

Based on the above stated assessment of the acute oral toxicity of the read across substance menthyl acetate, the results from a reliable with restrictions study are above the threshold value given in the CLP Regulation. Therefore, menthyl acetate and thus L-menthyl acetate does not need to be classified according to Regulation (EC) No. 1272/2008 (CLP) as implementation of UN-GHS in the EU.

Dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity, the read across substance menthyl acetate and thus L-menthyl acetate does not need to be

classified according to Regulation (EC) No. 1272/2008 (CLP) 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.