4-methyl-3-decen-5-ol

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vitro

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitising potential of the substance was evaluated on the basis of the results of two valid key studies.

Givaudan (1980b) determined the skin sensitisation potential of the test material in an open epicutaneous test in the guinea pig. A preliminary test was conducted to define the test concentrations for the definitive test; the maximum non-irritating and minimum irritant concentrations. In the definitive test, guinea pigs received daily topical induction applications of the test material in solution with ethanol at 100, 30, 10 and 3% for 21 consecutive days. A 0.1 mL aliquot of the appropriate test solution was applied to an area 8 cm² located on the flank of each animal and left uncovered. Each animal was challenged on the untreated flank on days 21 and 35 with a 10% of less test solution. The sensitisation potential was scored 24, 48 or 72 hours after challenge. Under the conditions of the test, the highest non-irritating concentration after a single application of the test material in ethanol was 10%. Only very slight skin irritation occurred with repeated applications. None of the tested animals elicited a positive reaction to the challenge exposure. Accordingly the test material was considered to be non-sensitizing.

Harrison (1981) determined the skin sensitisation of the test material in human volunteers in a repeat insult patch test (HRIPT). Forty human volunteers were exposed to the test material in a repeated insult patch test at a concentration of 10 %. Under the conditions of the test, no reactions were observed in any of the exposed volunteers and thus the test material was determined to be non-sensitising.

Both studies were performed to sound scientific principles and were assigned reliability scores of 2 in accordance with the principles for assessing data quality as set out by Klimisch (1997). Both studies provide sufficient information to assess the skin sensitisation of 4-methyl-3-decen-5-ol and a conclusion of non-sensitising to the skin was carried forward for risk assessment.

Migrated from Short description of key information:
Key study: None sensitising, open epicutaneous test (guinea pig), Givaudan. 1980b.
Key study: None sensitising, HRIPT (human), Harrison (1981)

Justification for selection of skin sensitisation endpoint:
The key study Anon. (1980) was submitted to fulfil the data requirements of this endpoint. This study pre-dates GLP and was performed to sound scientific principles following the open epicutaneous test methodology. The report includes sufficient detail to assign the study a reliability score of 2, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-sensitising.

The key study Harrison (1981) was submitted to fulfil the data requirements of this endpoint. The study was performed to sound scientific principles and was followed the HRIPT (Human Repeat Insult Patch Test) methodology). The report includes sufficient detail to assign the study a reliability score of 2, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-sensitising.

The endpoint was therefore addressed in line with the provisions detailed in Annex XI of REACH (Regulation EC 1907/2006) which states that historical human data shall be considered.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the EU Regulation EC 1272/2008 and Directive 67/548/EEC, the test material does not meet the criteria for classification for skin sensitisation.