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 145 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and tetradecan-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 145 and suitable for assessment purposes. Study data for each constituent has been evaluated and considered together. In a protective approach the most sensitive study results from across the three constituents has been identified and used to address the endpoint in question.

 

As detailed in Table 1 below, 4 skin sensitisation study reports are available for constituents of Alchisor TAL 145. Adequate reliable data is available for each constituent. Therefore using our protective approach the dataset is a reliable adequate basis for Alchisor TAL 145 assessment purposes.

 

Table 1: Sensitisation Key/Supporting Studies for Constituents of Alchisor TAL 145

 

 

Constituents of Alchisor TAL 145

 

Reference

Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%)

Dodecan-1-ol

Tetradecan-1-ol

Ilhama 1997

 

 

Key

Opdyke 1975

 

 

Supporting

Coombs 1977

Key

 

 

Lihama 1997

 

Key

 

 

In a reliable GLP compliant OECD 406 study the skin sensitising potential of Kalcol 4098 (tetradecan-1-ol) was assessed. There was no evidence of any sensitising potential and so tetradecan-1-ol was determined to be non-sensitising. This non-sensitising potential was confirmed in a further supporting study (Klimisch 4) whereby 50 human volunteers were exposed to tetradecan-1-ol in a petrolatum vehicle.

 

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.

 

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 145 indicate a lack of sensitisation potential. Consequently following the protective approach as detailed above, Alchisor TAL 145 is described as non-sensitising to skin.

Migrated from Short description of key information:
Alchisor TAL 145 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and tetradecan-1-ol.
Skin sensitisation study data for constituents of Alchisor TAL 145 indicate a lack of sensitisation. Consequently Alchisor TAL 145 is determined to be non-sensitising to skin.

Justification for classification or non-classification

The information presented in this dossier provides evidence that the constituents of Alchisor TAL 145 do not possess a skin sensitization potential. Consequently Alchisor TAL 145 does not require classification as a sensitiser as required by the current EU guideline.