Registration Dossier

Administrative data

Description of key information

skin irritation (OECD 404): irritating
eye irritation (OECD 405): highly irritating/corrosive
SCLs according to GHS:
>=10% - <20% Eye Irrit. Cat.2
<10% 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

According to the HERA report AS with longer carbon chains (C16-18) tend to be less irritating than AS with carbon chains of C12-15. Moreover, regarding the counter cation, the irritating potential decreases in the order potassium, sodium, ammonium.

The experimental data for skin and eye irritation show that AS have to be classified regardless the chain length as R38-41 (Skin Irri.2 - Eye Dam.1)

To set a specific concentration limit for the R36-41 (Eye Irri.2 - Eye Dam.1) cut off, the study conducted with C12-13, K (Cas # 91783-22-1) can be taken as reference. This substance represents a worst-case in the chain length as well as the counter cation and triggers at 22% a.s. a R36 (Eye Irrit.2) classification with borderline to R41 (Eye Dam.1). This justifies a SCL of 20% for all AS.

The first study conducted with C10-16, Na (Cas # 68585-47-7) shows,depending on the classification requirements, that the test substance is not or only moderate irritating to the eye at a concentration of 10% a.s. The second study with C10-16, Na (CAS#68585-47-7, analytical purity 10%) shows that the test substance is not irritating. Based on the above mentioned results with different concentrations of structurally related alkyl sulfates a cut of value for classification as severe irritating to eyes at 20% and for classification as irritating at 10% for all AS is justifiable.

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

Existing data indicate that for classification for skin and eye irritation is justified (R38-41).

Value used for CSA:

Skin irritation / corrosion: irritating

Eye irritation: highly irritating

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

>= 20%: R41

>=10% - <20%: R36


Justification for selection of skin irritation / corrosion endpoint:
Reliable OECD guideline study

Justification for selection of eye irritation endpoint:
Reliable OECD guideline study

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

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 Irritation Category 2, H315 and Eye Dam.1, H318, respectively.

It could be shown with experimental data on eye irritation that at 10 to 20% active substance only the classification Eye Irritating Category 2 according to Regulation (EC) No 1272/2008 and according to Directive 67/548/EEC only the classification R36 remains. Below 10% active substance no classification at all is necessary. Hence, the Generic Concentration Limits (GCLs) can be substituted by the mentioned specific ones (SCLs).