Pentane-1,2-diol

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Sensitization to skin was assessed in a Maurer Optimisation test conducted as stated in the Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics (1959) by the US association of Food and Drug Officials (Maurer, 1982). Thereby, ten male and ten female Pirbright white strain Guinea pigs received ten intradermal injections of 0.1% pentane-1,2-diol in physiological saline and in mixture with complete Bacto Adjuvant (vehicle : adjuvant, 1:1). 14 days after the last induction injection, a challenge injection of 0.1 ml , 0.1% pentane-1,2-diol in physiological saline, and another ten days later, 10% in vaseline was applied epicutaneously under occlusion for 24 hours. As result, no difference between test animals and untreated control animals was seen, so that pentane-1,2-diol did not show skin-sensitizing potency in albino Guinea pigs.

In addition to the studies with Guinea pigs, a Repeated Insult Patch Test with humans (see 7.10.4) could be taken into account for assessment. In this study, 53 of 60 volunteers finished the study, where they received nine applications of 0.2 ml of 50% pentane-1,2-diol in water for 24 h. Approximately two weeks later, a challenge application was performed and reactions were scored 24 and 72 hours post-application. As result, none of the subjects showed any sensitizing effects.

Migrated from Short description of key information:
Sensitization:
- skin: not sensitizung (Maurer Optimisation test; acc. FDA; HRIPT)

Justification for classification or non-classification

Due to the negative results in studies with Guinea pigs and human, no classification as sensitizing is required.