Registration Dossier

Administrative data

Description of key information

skin irritation (OECD 404): irritating
eye irritation (OECD 405): highly irritating/corrosive
SCLs according to GHS:
>=5% - <10% Eye Irrit. Cat.2
< 5% No Classification

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Several skin and eye irritation studies with alcohol ethoxysulfates (AES) have been conducted on rabbits considering different concentrations, exposure duration and exposure conditions (HERA AES, 2003).

These irritation studies indicate that the irritation potential of AES is concentration dependent. For the neat substances, the effects in rabbits are moderate to severe. As neat AES are irritant to skin and eyes, according to the EU classification criteria AES will be classified as skin and severe eye irritant (R38, R41 and Skin Irri.2, Eye Dam.1, respectively).

To set a specific concentration limit for the R36-41 (Eye Irri.2 - Eye Dam.1) cut off, additionally read across from structurally related AES was performed. The AES reported within the AES category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read across approach between structurally related AES. For details please refer to the category justification attached in IUCLID section 13. The study conducted with AES (C12-14, 4 EO) Na (CAS 68891-38-3) can be taken as reference (Kukulinski, 1980a). This study shows that the test substance is irritating to the eye at a concentration of 10% a.s. The second study performed with AES (C12-14, 4 EO) Na (CAS 68891-38-3) shows the same substance to be not irritating to the eye at a concentration of 5% (Kukulinski, 1980b). In the study with AES (C12-14, 2 EO) Na (CAS 68891-38-3) the test substance was not irritating to eyes at a concentration of 5.4 % (Biffi, 1997). However in a study with AES (C10-16, 2 EO) Na (CAS68585-34-2, no data on grade of ethoxylation) the test substance showed eye irritating properties at a concentration of 5%. Thus, 5% represents the borderline value for classification as eye irritation.

Based on the above mentioned results with different concentrations of structurally related alkyl ether sulfates a cut off value for classification as severe irritating to eyes is set at a concentration of 10% and for classification as irritating at a concentration of 5% for the AES of the category.

The following information is taken into account for any hazard / risk assessment:

The substance has to be classified with R38 and R41.

Value used for CSA:

Skin irritation / corrosion: irritating

Eye irritation: highly irritating/corrosive

Specific concentration limits for eye irritation can be set as follows:

>= 10%: R41; Eye Dam.1, H318

>=5% - <10%: R36; Skin Irrit. 2, H315

References:

Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28

HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject.com.


Justification for selection of skin irritation / corrosion endpoint:
No study selected as weight of evidence-approach was used.

Justification for selection of eye irritation endpoint:
No study selected as weight of evidence-approach was used.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance needs to be classified with Xi, R38/R41 and Skin Irrit. 2, H315 and Eye Dam.1, H318, respectively.

It could be shown with experimental data on eye irritation that at about 10% active substance only the classification Eye Irrit. Cat.2 remains and below 5% active substance no classification at all is necessary. Hence, the Generic Concentration Limits (GCLs) can be substituted by the mentioned specific ones (SCLs).

Due to the fact, that these SCLs comply with the generic ones set in Directive 1999/45/EC (DPD), SCLs will only be applied according to Regulation (EC) 1272/2008 (CLP).