Registration Dossier

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:

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol. As defined in the Read-across Justification Document in section 13, data provided for these constituents when considered together is representative of Alchisor TAL 123 and suitable for assessment purposes. Study data for each constituent has been evaluated. In a protective approach the most sensitive study result from across the three constituents has been identified and used to address the hazard endpoint in question.

 

4 skin sensitisation study reports are available for constituent/constituent classes of Alchisor TAL 123. This endpoint includes one Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), one undecan-1-ol and one dodecan-1-ol sensitisation studies. In addition read across data is provided for undecan-1-ol. Adequate reliable data is available for each constituent. Therefore using a conservative approach the dataset is a reliable adequate basis for Alchisor TAL assessment purposes.

 

The sensitization potential of dilutine M5 (identified as hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)) was assessed in a guinea pig maximization test (Coombs 1997). Intradermal induction of the test item at 0.1 % w/v in corn oil was followed by a topical induction of 50% w/v in corn oil and a challenge of 25.0% w/v in corn oil. No skin response was reported in any of the test animals (10/sex) and so the test item was deemed non-sensitizing. This finding is further confirmed by a dermal sensitisation study in humans (ExxonMobil 1962). 101 volunteers (age 19-62) were exposed to test compounds (representing C9-C14 aliphatics (2-25% aromatics)) for 4-6 hours. Following the initial patch the test materials were to the subjects' forearms once or twice daily, five days a week, for three weeks. None of the test materials were found to be skin sensitizers.

A combination of a read across argument and a weight of evidence approach have been developed in connection with the sensitizing potential of undecan-1-ol. Sharp 1978 assessed the sensitizing potential of hexanol (CAS 111-27-3) in a guinea pig non-adjuvant modified Draize sensitization procedure. Hexan-1-ol was reported not to be a skin sensitiser in guinea pigs following intradermal and topical challenge after 2 series of induction applications. To further support the non-sensitising potential of undecan-1-ol and the category read across approach detailed with hexan-1-ol Opdyke 1973 reported on a sensitization study in humans. A human maximization study (reliability 4) was conducted with undecan-1-ol in 25 human volunteers. Undecan-1-ol at 4% in petrolatum produced no sensitization reactions. Dodecan-1-ol was assessed for sensitization potential according to OECD 406 in a guinea pig maximisation test (Iihama 1997). In this reliable (Klimisch 1) and GLP compliant study dodecan-1-ol was reported not to be sensitising.

 

Sensitisation study reports presented for constituents of Alchisor TAL 123 indicate a lack of sensitisation potential. Consequently following the protective approach as detailed above, Alchisor TAL 123 is described as non-sensitising to skin.

Migrated from Short description of key information:
A guinea pig maximization test was conducted with hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) according to OECD 406 (Coombs 1977). The test substance did not cause any skin response during the challenge procedure and so is considered not sensitizing. Weight of evidence across the category suggests that undecan-1-ol is not sensitizing to skin. A read across from hexan-1-ol has been provided in support of this result (Sharp 1978). The key study for dodecan-1-ol skin sensitization was a guinea pig maximization test. In this study the test material was found to be not sensitising to skin (Iihama, 1997).

Respiratory sensitisation

Endpoint conclusion
Additional information:

The information presented in this dossier provides evidence that the constituents of Alchisor TAL 123 do not possess a skin sensitization potential. Consequently Alchisor TAL 123 does not require classification as a sensitiser as required by the current EU guideline.

Justification for classification or non-classification