Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 218-690-9
CAS number: 2216-51-5
Low acute toxicity for oral route (LD50 >2000 mg/kg bw).Low acute toxicity dermal (LD50 >5000 mg/kg bw)Low acute toxicity inhalative (LC50 (aerosol, 4h) 5289 mg/m3)
Justification for Read-across:
Based on the identical profiles of the different Menthols and supported
by the Read-Across Justification for Menthols (see file
MentholsReadAcrossFinal.pdf in section 13) we use all studies on
stereoisomers of L Menthol for read across . These isomers are L Menthol
(CAS 2216-51-5), D Menthol (CAS 15356-60-2) and DL Menthol (CAS 89-78-1).
Moreover, a comparative physico-chemical profile of these isomers
reinforces this similarity. As structural isomers, the members of the
Menthol category share the same molecular weight. Of
particular importance to environmental effects and human effects are the
values for partition coefficient (log Kow around 3), vapour pressure
(from 17 Pa at 25°C for the DL Menthol to 21 Pa 25°C for the natural L
Menthol ) and water solubility ( moderately soluble from 410 mg/l at
25°C for the natural L Menthol to 470 mg/l at 25°C for the DL Menthol).
The read across is consistent based on these physico-chemical parameters.
Details on the Acute toxicity studies :
value of 3.4 g/kg for L-Menthol was determined in mice. An oral LD50
value in rat was found to be
g/kg bw for
L Menthol, 2,6
g/kg bw for
DL Menthol, and
g/kg bw for
D Menthol .
studies, one with racemic menthol (Menthol RC composed of DL Menthol
77%, Iso Menthol 10%, NeoIso Menthol 5%, Para Menthol 4%, and Neo
Menthol 1%) and one with DL Menthol administered to NMRI mice by gavage
resulted in a LD50 value of 1.47 g/kg bw and 9 ml/kg bw, respectively.
The studies are not regarded to be relevant for classification. Because
only 2 animals per dose were used, the influence of the non DL, D and L
Menthol isomeres on the potency is not clear and in case of the of 9
ml/kg bw dose no information was found to translate the result into a
mg/kg bw value.
It can be assumed that L-Menthol has a low acute oral toxic
The acute inhalative toxicity testing was determined in an OECD
403 study using rats, administering DL Menthol as aerosol. The LC50 in
this study (4 hours exposure) was determined to be 5289 mg/m3 and
therefore Menthols are considered to have a low acute inhalative toxic
The acute dermal LD50 of L Menthol in rabbits was determined to be
greater than 5 g/kg bw.
It can be assumed that L Menthol has a low acute dermal toxic
In a study performed by intraperitoneal application a LD50 of
1.5g/kg bw was determined. Since intraperitoneal application is not seen
to be a relevant exposure route, this study will not be further
Taken all information and application ways together L Menthol is
considered as having a low acute toxic potential
performed by oral and dermal exposure indicate LD50 values beyond the
limits for classification and hence L Menthol does not meet the criteria
for classification and labelling for these endpoints, as set out in
Regulation (EC) No 1272/2008 or in Directive 67/548/EEC respectively.
Inhalative exposure to DL Menthol aerosol resulted in an LC50 of 5289
mg/m3 and therefore was found also to be not indicative for
classification under CLP (Regulation (EC) No 1272/2008).
target organ toxicity: According to CLP classification criteria, the
substance does not meet the criteria for classification and labelling
for this endpoint (STOT single exposure) as set out in Regulation (EC)
No. 1272/2008 as no indications were observed in acute animal studies.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again