Registration Dossier

Administrative data

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. 
The most sensitive endpoint for eye irritation/corrosion is based on an acute irritation study with tetradecan-1-ol (Klimisch 1). In this study tetradecan-1-ol was found to be moderately-irritating according to Kay and Calandra assessment criteria and a category 2 eye irritant according to current guidelines. Consequently Alchisor TAL 145 is determined to be moderately-irritating to eyes and a category 2 eye irritant according to current guidelines.

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)

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.

 

Skin Irritation/Corrosion

 

As detailed in Table 1 below, 16 skin irritation/corrosion 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: Skin Irritation/Corrosion 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

Kuhn 1990

Key

 

 

Henkel 1996

 

Key

 

Sanders 1996

 

Supporting

 

Hempstock 1997

 

Supporting

 

Scientific Associates 1975

 

Supporting

 

Henkel 1996

 

 

Key

Scientific Associates 1977

 

 

Supporting

Henkel 1996

 

 

Supporting

IUCLID 2000a

 

 

Supporting

Opdyke 1975

 

 

Supporting

Opdyke 1975

 

 

Supporting

IUCLID 2000b

 

 

Supporting

RTECS 2004

 

 

Supporting

IUCLID 2000c

 

 

Supporting

IUCLID 2000d

 

 

Supporting

IUCLID 2000e

 

 

Supporting

 

Skin irritation has been investigated in studies conforming tobothstandard 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 key study for skin irritation with tetradecan-1-olwas chosen as it was the most recent, high reliability study available with data from man. This study reported that tetradecan-1-ol was not irritating to the skin of healthy volunteers. However it should be noted that a supporting study (Klimisch 2) was also available; with results in rabbit which finds tetradecan-1-ol a class 2 irritant when interpreted according to EU criteria.The rest of the supporting studies for tetradecan-1-ol are Klimisch 4 and may not be used for classification purposes; however, they support the existing key study by finding the test material at the most slightly irritating to skin.

 

Reliable skin irritation/corrosion studies for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and tetradecan-1-ol provides evidence as to the skin irritancy/corrosive potential of Alchisor TAL 145. Reliable study results from across the constituents of Alchisor TAL 145 indicate a non-irritation potential. As a consequence of this study information and in line with our protective approach Alchisor TAL 145 is determined not to be a skin irritant.

 

Eye Irritation/Corrosion

 

As detailed in Table 2 below, 7 eye irritation/corrosion 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 2: Eye Irritation/Corrosion 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

Sanders 1996a

 

 

Key

Hempstock 1997

 

 

Supporting

Scientific Associates 1977

 

 

Supporting

IUCLID 2000

 

 

Supporting

Opdyke 1975

 

 

Supporting

Kuhn 1990

Key

 

 

Sanders 1996b

Key

 

 

 

A primary eye irritation study (Klimisch 1) reported that C9-C14 aliphatics (2-25% aromatics) were not irritating to the eye (Kuhn 1990). A reliable (Klimisch 1) OECD 405 study, reported that dodecan-1-ol was not irritating to the eye of NZW test rabbits (Sanders 1996).

 

In a reliable (Klimisch 1) guideline study, Kalcol 4098 (tetradecan-1-ol) was applied to the eyes of 3 NZW rabbits. On the basis of cornea scores of 1 in all three animals and conjunctivae redness and chemosis reading of 2 in two of the animals (Kay and Callandra assessment criteria), the test material was determined to be moderately irritating. The test item in this instance would be a category 2 irritant according to current guidelines (Sanders 1996). Studies evaluated for both C9-C14 aliphatics (2-25% aromatics) and dodecan-1-ol have reported endpoints that are less sensitive. A primary eye irritation study (Klimisch 1) reported that C9-C14 aliphatics (2-25% aromatics) were not irritating to the eye (Kuhn 1990). A reliable (Klimisch 1) OECD 405 study, reported that dodecan-1-ol was not irritating to the eye of NZW test rabbits (Sanders 1996).

 

As a consequence of this study information and in line with our protective approach Alchisor TAL 145 is determined to be moderately irritating to the eye and a category 2 eye irritant according to current guidelines.


Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on the available information, Alchisor TAL 145 does not require classification or labelling for skin irritation, but it is proposed to be irritating to eye (Cat. 2) in accordance with current EC regulation 1272/2008 (CLP).