Isotridecan-1-ol

Endpoint summary

Description of key information

No skin sensitization was observed for Isotridecanol and two similar branched alcohols: Isononanol and Isodecanol

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

see justification attached to chapter 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Remarks on result:

no indication of skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Since data for the registered substance are limited, data from related branched alcohols were additionally included in the IUCLID dossier. A detailed read across justification is attached to IUCLID chapter 13.

CAS 25339-17-7 (Iso-decanol)

In a modified Draize test, Sharp et al. (1978) injected 10 guinea pigs with 2.5 times the concentration that gave barely perceptible irritation in a preliminary irritation test, i.e., 0.25%, of isodecanol. Two weeks later, the animals were challenged intradermally with 0.1% and topically with 10% (a concentration that does not cause irritation). With the exception of the induction treatment, control animals were treated the same. Isodecanol did not cause skin sensitization in this assay.

CAS 27458-94-2 (Isononanol)

A Buehler test was performed with Isononanol by BASF in 2008. 0.5 ml of undiluted test substance was applied under occlusive dressing to each of the 20 guinea pigs in the test group for 6h. The application was repeated three times at weekly intervals at the same skin site. Fourteen days after the last induction treatment, all animals including the 10 control animals were dermally exposed to 0.5 ml of undiluted test substance under occlusive conditions for 6h. Skin reactions were read after 24 and 48h. No skin reaction was observed in any of the 10 control and 20 test animals. A routinely performed positive control with Alpha-Hexylcinnamaldehyde showed the expected results. Consequently, Isononanol did not cause skin sensitization in this assay.

CAS 27458-92-0 (Isotridecanol, registered substance)

Data for Isotridecanol are only available from a secondary source (Bibra 1988) and contain only a limited amount of information, but they confirm the absence of skin sensitizing properties determined with the related branched alcohols. An intracutaneous test was conducted with 70% branched chain primary isomers of Tridecanol and 30% Pentadecanol as test substance. In a group of 20 guinea pigs an unspecified number of intradermal injections of a 1% mixture of the test substance in liquid paraffin were followed 1 week later by the topical application (probably covered, 48h) of a similar 5% solution. A topical challenge with 0.1% of the same mixture in liquid paraffin (probably covered, 48 h) given 2 weeks later produced no reactions.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No skin sensitization was observed for Isotridecanol and two similar branched alcohols: Isononanol and Isodecanol. Consequently, no classification according to 1272/2008/EC (CLP) criteria is required.