4-methylpentan-2-ol

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitization potential of methyl iso butyl carbinol was assessed in a study performed according to OECD Guidelines for the Testing of Chemicals No. 406 and in compliance with GLP in male and female Dunkin-Hartley guinea pigs (de Jouffrey, 1997).  In the main study, 10 animals/sex comprised the methyl iso butyl carbinol test group and 5 animals/sex comprised the vehicle control group.  The intradermal induction was carried out with 0.1 mL of 1% (w/w) of methyl iso butyl carbinol in vehicle (paraffin oil), and epicutaneous induction was performed with 0.5 mL of undiluted methyl iso butyl carbinol to the dorsal area under occlusive conditions.  The challenge exposure also was conducted with 0.5 mL of undiluted methyl iso butyl carbinol.  Additionally, all animals were dermally exposed to 0.5 mL of 10% w/w sodium lauryl sulphate (SDS) in vaseline 24 hours prior to topical sensitization of the skin area in order to induce local irritation (methyl iso butyl carbinol was shown to be non-irritating in the preliminary test).  Skin reactions were observed and recorded 1 hour after dermal and 24 and 48 hours after the challenge exposure, all according to the grading scale by Magnusson and Kligman.  Hypoactivity and piloerection were observed on Day 7 in one animal of the control group and it was found dead on Day 8. Macroscopic examination of the main organs of the animal found dead revealed no abnormalities and the authors determined that these findings were not attributed to treatment. Other control animals and test animals displayed normal body weight gain throughout the investigation and no mortalities or clinical signs were observed in these animals.  Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of methyl iso butyl carbinol were observed in guinea-pigs.  Therefore, the results of this study demonstrated that methyl iso butyl carbinol showed no evidence of contact skin sensitization in guinea pigs.

Migrated from Short description of key information:
A skin sensitization study in animals was negative and indicates that MIBC is not likely to be a sensitizer in humans

Respiratory sensitisation

Endpoint conclusion

Additional information:

No data available.

Justification for classification or non-classification

The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.