Registration Dossier

Administrative data

Description of key 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. 
Reliable study results from across the constituents of Alchisor TAL 123 indicate a non-irritation potential. As a consequence of this study information and in line with the protective approach Alchisor TAL 123 is determined not to be a skin irritant.
The most sensitive endpoint for eye irritation reports mild irritation (under GHS criteria) following application of undiluted undecan-1-ol to the eyes of rabbits (Younger Laboratories 1972).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

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 (see the Read-across Justification Document in Section 13). Study data for each constituent has been evaluated. In a protective approach study results from across the three constituents have been identified and used to address the hazard endpoint in question.

 

 

Skin Irritation/Corrosion

12 study reports are available as evidence of the skin irritation/corrosion potential of Alchisor TAL 123. This endpoint includes one Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), six undecan-1-ol and four dodecan-1-ol skin irritation/corrosion studies. In addition one Alchisor TAL 123 specific study (Klimisch score 4) is also included. Adequate reliable data is available for each constituent. Therefore using a protective approach the dataset is a reliable adequate basis for Alchisor TAL assessment purposes.

 

Skin irritation has been investigated in studies conforming to both standard guidelines (OECD 404) and non-standard methods. A reliable (Klimisch 1) primary dermal irritation study in rabbits (Kuhn 1990) reported that C9-C14 aliphatic solvents (2-25% aromatics) were not irritating according to both EC and GHS criteria. Furthermore In a reliable (Klimisch 1) human study it was reported that dodecan-1-ol was not irritating.

 

The skin irritancy potential of undecan-1-ol was assessed in a reliable (Klimisch 2) OECD 404 equivalent study (Jacobs & Martens 1992). Undecan-1-ol was applied to six rabbits at three different doses; undiluted and 25% and 50% in polyethylene glycol MW 400. Following a 4 hour occlusive exposure to rabbit skin undiluted undecanol was found to be irritant, according to both EU and GHS criteria (Category 2). Two reliability 2 supporting studies which used undiluted test substance were available also. The first of these, Biolab SGS (1985) reports skin irritation scores that fall just below that which would classify as irritant according to the EU guideline. Younger Labs (1977) is in accordance with the key study, reporting undecanol to be irritating to rabbit skin. However, a study by Jacobs et al. (1978; rel 2) carried out in man and rabbit finds the test substance irritating in rabbit but not in man, which is taken into account in the justification for classification or non-classification. An unreliable skin irritation study (Klimisch 4) specifically with Alchisor TAL 123 reported that the test substance was not irritating.

 

Reliable skin irritation/corrosion studies for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol provides evidence as to the skin irritancy/corrosive potential of Alchisor TAL 123. Reliable study results from across the constituents of Alchisor TAL 123 indicate a non-irritation potential. As a consequence of this study information and in line with our protective approach Alchisor TAL 123 is determined not to be a skin irritant.

 

 

Eye Irritation/Corrosion

6 study reports are available as evidence of the eye irritation/corrosion potential of Alchisor TAL 123. This endpoint includes one Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), one dodecan-1-ol and three undecan-1-ol skin irritation/corrosion studies. In addition one Alchisor TAL 123 specific study (Klimisch score 4) is also included. Adequate reliable data is available for each constituent. Therefore using a protective approach the dataset is a reliable adequate basis for Alchisor TAL assessment purposes.

 

A primary eye irritation study (Klimisch 1) reported that Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) were not irritating to the eye (Kuhn 1990). A reliable (Klimisch 2) OECD 405 GLP complaint study (Scientific Associates 1975) reported that dodecan-1-ol was irritating to the eyes of NZW test rabbits. According to EU criteria, the test substance would be a category 2 eye irritant.

 

In a reliable but non-guideline study, undiluted undecan-1-ol was applied to the eyes of 3 male and 3 female rabbits. Test animals where observed for 7 days and eye washing was conducted after the 24 hour reading.Undecan-1-ol is described as slightly irritating to the eye in this test. Under GHS criteria the results suggest classification as category 2 irritant to the eye (Younger Laboratories 1972). An unreliable eye irritation study (Klimisch 4) specifically with Alchisor TAL 123 reported that the test substance was not irritating.

 

Study reports for both undecan-1-ol and dodecan-1-ol provide the most sensitive results for constituents of Alchisor TAL 123. Consequently following the protective approach as detailed above Alchisor TAL 123 is described as category 2 eye irritant according to GHS criteria.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the available information, Alchisor TAL 123 does not require classification or labelling for skin irritation, but it is proposed to be a irritating to eye (Cat. 2) in accordance with current EC regulation 1272/2008 (CLP).