Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The potential for tertiary butyl alcohol to cause dermal sensitization is well understood.  In a Guinea Pig Maximization Test conducted according to OECD Guidelines, a concentration of 100% tertiary butyl alcohol at challenge did not cause a sensitization reaction in female guinea pigs after prior intradermal exposures of 1% and topical exposures of 100%.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No information available.

Justification for classification or non-classification

No evidence of a sensitization response was observed in a guideline dermal sensitization study conducted in guinea pigs and the subject chemical is not structurally similar to substances known to cause dermal sensitization. Based on a weight-of-the evidence assessment, tertiary butyl alcohol is not classified for dermal sensitization according to Dangerous Substances Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.