Dimethylcyclohex-3-ene-1-carbaldehyde

Endpoint summary

Description of key information

Skin sensitisation: The substance is a skin sensitizer 1B, though an EC3 could not exactly be derived; NOEC was derived of 5% in an LLNA (OECD TG 429)

Skin sensitisation in an HRIPT test: At 1% non-sensitising

Respiratory sensitisation: No adverse effects observed

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The available data on skin sensitisation on Vertoliff is summarized below. 

 

Vertoliff: OECD TG 429 (LLNA)

The skin sensitisation potential of the test substance has been tested using the Local Lymph Node Assay (LLNA) according to OECD TG 429, EPA OPPTS 870.2600 and GLP. The application of the test substance at concentrations of 1, 2.5, 5, 10 and 25% (v/v) in ETOH/DEP (1:3) resulted in SI indexes of 2.1, 2.0, 2.9, 4.2 and 2.7, respectively. At 10% the SI is > 3 and therefore the substance is considered a skin sensitizer. An EC3 is difficult to estimate because of the absence of a dose response when tested up to 25%. The 25% result, however, may be confounded due to skin irritation. A NOEC can be derived, which is set at 5% (SI 2.9).

 

Vertoliff: HRIPT

An HRIPT test was performed with 1% test substance. 106 volunteers finished the study and they were exposed to 0.2 mL solution at 25 mm under occlusive conditions. The subjects removed the bandages 24 hours after application. The basic schedule was kept in the induction phase every Monday, Wednesday and Friday till 9 applications had been made. The test patch was applied to the same site each time, unless reaction to sample rendered this inadvisable, in which case the test patch was applied to a distant site. After two weeks a challenge patch was applied to a site not previously exposed and removed after 24 hours. Reactions to the challenge were assessed after 24, 72 and 96 hours. None of the 106 subjects tested was sensitized by the sample. In addition, for one subject who showed a mild and transient response, a re-challenge was performed 6 weeks after the study. From occlusive, semi-occlusive and open application it was concluded that the substance is not associated with an allergic dermatitis response. Under the conditions of the test 1% test substance was not sensitising.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

This endpoint can be assessed using human data such as indicated in R7.3.5.2 of the ECHA guidance (2015) that indicate respiratory reactions e. g. from consumer experience or occupational exposure. In case no such data are available, the respiratory sensitisation can be assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-2, 2015). Based on this strategy, Vertoliff is not a respiratory sensitizer, because it is not a di-isocyanate, it does not have any other structural alerts (like acid anhydride or platinum salt, etc.) and there are no other reasons to suppose potential respiratory sensitization hazard of Vertoliff.

Justification for classification or non-classification

According to EU CLP (EC No. 1272/2008 and its amendments), the substance is classified as a skin sensitiser category 1B (May cause an allergic skin reaction, H317). The substance is not a respiratory sensitiser in absence of human data indicating such effects which is according to EU CLP (EC No. 1272/2008 and its amendments) and following the ECHA guidance.