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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information
no data
Effect on fertility: via oral route
Dose descriptor:
NOAEL
375 mg/kg bw/day
Additional information

Groups of 50 rats of each sex were administrated dl-menthol at one of the following doses, either 3750 or 7500 ppm (= ca. 188 or 375 mg/kg bw/d) for 103 weeks. At the end all animals were killed and necropsied; gross and microscopic examination of: all major organs, including reproductive organs; in male rats prostate,testes, epididymis, scrotum; in female rats mammary gland, vagina, uterus, uterus/endometrium, ovary/panovarian, ovary.

Histopathological examinations of the reproduction organs of rats showed no changes in the repeated dose toxicity studies with D/L-menthol and also in carcinogenicity studies with D/Lmenthol. Hence there is no indication of a potential of D/L-menthol to interfere adversely with reproduction.

In the analogue study in mice also no indication of a potential of D/L-menthol to interfere adversely with reproduction was found.


Short description of key information:
A carcinogenicity study with histopathologic examiniation of male and female reproduction organs in rats and mice was performed

Effects on developmental toxicity

Description of key information
The administration of up to 218 mg/kg (body weight) of the test material to pregnant rats for 10 consccutive days had no clearly descernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
The administration of up to 405 mg/kg (body weight) of the test material to pregnant hamsters for 5 consecutive days had no clearly
discernible effect on nidation or on maternal or fetal surviva1. The number of abnormalities seen in either soft or skeletal tissues of the test groupn did not differ from the number occurring spontaneously in the sham-treated controls.
The administration of up to 185 mg/kg (body weight) of the test material to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
The administration of up to 425 mg/kg (body weight) of the test material to pregnant rabbits for 13 consecutive days had no clearly
discernible effect on nidation or on maternal or fetal survival. The number of abnorrnalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
218 mg/kg bw/day
Additional information

development toxicity/teratogenicity studies on rats, rabbits, mice and hamsters revealed no evidence of teratogenic effects of menthol.

Toxicity to reproduction: other studies

Additional information

no data

Justification for classification or non-classification

From the available data a classification is not justified

Additional information