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Administrative data

Description of key information

In a valid 2 years oral feed study in rats the NOAELs were 375 mg/kg bw/d for male rats and 667 mg/kg bw/d for male and female mice. For female rats the NOAEL is 188 mg/kg based on slightly reduced body weight at 375 mg/kg bw. For repeated dermal and inhalative toxicity no valid studies are available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
188 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Scientifically acceptable and well documented carcinogenicity study.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral exposure

Mean body weights of dosed rats were only slightly lower than those of corresponding controls. No other clinical signs related to administration of the dl-menthol were noted in the dosed groups of animals. Based on the histopathological examination, dl-menthol was neither toxic nor carcinogenic to Fisher 344 rats under the conditions of this bioassay.

Mean body weights of dosed mice were only slightly lower than those of corresponding controls. No other clinical signs related to administration of the dl-menthol were noted in the dosed groups of animals. Based on the histopathological examination, dl-menthol was neither toxic nor carcinogenic to B6C3F1 mice under the conditions of this bioassay.

Exposure by inhalation

There is one study from 1954 (Rakieten) available with exposure to L-menthol by whole body vapour inhalation for 71 to 79 days with male and female Sherman rats (groups of 12). As the measurement of the exposure concentration does not seem reliable, this study cannot be used to derive a NOAEL. However, it points to the respiratory system as possible target organ after exposure by inhalation (OECD SIDS for menthols, UNEP publication 2003).

Oral exposure

No valid studies available.

Justification for classification or non-classification

Based on these data a classification according to CLP classification criteria (Regulation (EC) No 1272/2008) is not justified