Registration Dossier

Administrative data

Description of key information

No data is available for (±)-neomenthol. Reliable data are available from L-menthol.

L-menthol and thus (±)-neomenthol is not skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to IUCLID section 13 for a detailed justification of the category approach.
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25% w/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% w/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Remarks on result:
no indication of skin sensitisation
Parameter:
SI
Value:
1.3
Test group / Remarks:
1% w/v
Parameter:
SI
Value:
1.8
Test group / Remarks:
10% w/v
Parameter:
SI
Value:
0.91
Test group / Remarks:
30% w/v
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 1% w/v : Counts per minute (cpm)=1212 10% no effects : Counts per minute (cpm)=2234 30% no effects : Counts per minute (cpm)=1131
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The test substance is not considered to be a skin sentizer as observed in the LLNA and Buehler tests in guinea pigs.
Executive summary:

A LLNA test and a Buehler test are available from structural analogue L-menthol (CAS 2216 -51 -5). It is concluded that (±)-neomenthol is not skin sensitising. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the skin sensitising potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no reliable skin sensitisation study on (±)-neomenthol available.

Justification for Read-across:

Based on the identical profiles of the different menthols and supported by the Read-Across Justification for menthols (IUCLID chapter 13) all studies on stereoisomers of (±)-neomenthol are used for read across. These isomers are L-menthol (CAS 2216-51-5), (+)-menthol (CAS 15356-60-2), D/L-menthol (CAS 1490 -04 -6) and 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 Pow between 3.12 and 3.45 at 25°C), vapour pressure (from 3.6 to 21 Pa at 25°C) and water solubility (moderately soluble from 231 to 456 mg/L at 25°C). The read across is consistent based on these physico-chemical parameters.

Details on skin sensitising potential of L-menthol:

An LLNA study according to OECD 429 was performed with L-menthol (1995). L-menthol at concentrations of 1, 10 and 30% w/v was tested. The increase in isotope incorporation was less than 3-fold at all concentrations. Also the response was not consistent with a biological dose-response. The SI values were 1.3, 1.8 and 0.91 at 1, 10 and 30% L-menthol concentrations, respectively. Consequently, L-menthol is not a skin sensitiser.

A Buehler test (according to OECD 406) was performed with L-menthol (1991). Following dose ranging a concentration of 25% w/v in ethanol : DEP was selected for induction and challenge. At challenge, none of the test and control animals treated with L-menthol at a concentration of 25% w/v in ethanol : DEP showed a positive response. Consequently, there is no evidence from these test results that L-menthol is a skin sensitiser in guinea pigs.

In conclusion, L-menthol and thus (±)-neomenthol is not sensitizing and consequently does not require classification for this endpoint as set out in Regulation (EC) No. 1272/2008.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

(±)-neomenthol does not meet the criteria for classification and labelling as skin sensitiser as defined in Regulation (EC) No. 1272/2008 .