Registration Dossier
Registration Dossier
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EC number: 282-015-4 | CAS number: 84082-70-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha piperita, Labiatae.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No selection is made as a Weight of Evidence approach with constituent data was followed which is described below.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No information is available for cornmint or peppermint oil, however, no effects on development and/or reproduction were observed for 70.6% of the constituents. In the table below the available information on constituents is summarized.
Constituent |
Developmental toxicity/Toxicity to reproduction |
NOAEL |
Major constituents (≥10%) |
||
L-menthol |
Developmental toxicity (rat) |
No developmental effects observed 218 mg/kg bw /day |
Menthone |
RA to L-menthol Developmental toxicity (rat) |
No developmental effects observed 218 mg/kg bw /day |
Minor constituents (<10%) |
||
L-limonene |
Developmental toxicity (rat, rabbit, mouse) |
No developmental effects observed 591 mg/kg bw/d (rat) >1000 mg/kg bw/d (rabbit) 591 mg/kg bw/d (mouse) |
Alpha-pinene |
RA to Camphene Developmental toxicity (rat) |
No developmental effects observed 250 mg/kg bw /day |
Beta-pinene |
RA to Alpha-pinene/Camphene Developmental toxicity (rat) |
No developmental effects observed 250 mg/kg bw /day |
Myrcene |
One generation toxicity to reproduction (rat) Developmental toxicity (rat) |
300 mg/kg bw/d
500 mg/kg bw/d |
For the remaining constituents also no effects on development or reproduction are expected, as most of the constituents are structurally similar (terpenes, terpenoids). Based on the absence of effects on development and reproduction in the major and some minor constituent, cornmint oil and peppermint oil are not expected to be toxic to the development or reproduction.
Justification for selection of Effect on developmental toxicity: via oral route:
No selection is made as a Weight of Evidence approach with constituent data was followed which is described below.
Justification for classification or non-classification
Based on the available information on constituents, peppermint oil does not have to be classified for developmental or reproduction toxicity in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
