Registration Dossier

Administrative data

Description of key information

Skin irritation: The read across substance sodium sulphooctadecanoate (CAS 67998-94-1) was tested for its acute skin irritation potential in rabbits. Only slightly skin irritating effects were observed. According to these results the substance can be considered to be not skin irritating. 
Eye irritation: The read across substance sodium sulphooctadecanoate (CAS 67998-94-1) was tested for acute eye irritation on three rabbits (Kleinrussen, Chbb:HM) by a 24 hours contact test according to OECD guideline 405. The test substance showed eye damaging and no reversible effects.

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

A read across approach was applied for skin and eye irritation using data of the similar sodium sulphooctadecanoate (CAS 67998-94-1). This substance is considered to show similar toxicological properties as compared to the test item as the only difference is the sodium ion instead of the potassium ion.

Skin irritation

The substance sodium sulphooctadecanoate (CAS 67998-94-1) was tested for its acute skin irritation according to OECD guideline 404. The substance was applied on the shaved back skin of three rabbits (Kleinrussen, Chbb:HM) in an amount of 0.5 mL for 4 hours semiocclusively. After 72 hours the animals were examined. The following scores (mean score after 24, 48, 72 hours) were observed:

Erythema: 0.33, 0.33, 0.33 (all scores fully reversible within 48 hours)

Edema: 0, 0, 0

Slightly skin irritating effects were observed. According to these results the substance can be considered to be non-irritating.

Eye irritation

The undiluted read across substance sodium sulphooctadecanoate (CAS 67998-94-1) was tested for acute eye irritation on three rabbits (Kleinrussen, Chbb:HM) by a 24 hours contact test according to OECD guideline 405. The test substance was applicated in an amount of 0.1 mL. The animals were examined 1, 24, 48, 72 hours and 7, 14, 22 days after application. The test substance was removed with warm water after 24 hours. 0.5 % fluorescein-sodium solution was used to assess the scores, according to Draize et al. The mean scores at 24, 48, 72 hours obtained from 3 animals were as following:

Cornea: 1 (not reversible after 21 days), 1, 1

Chemosis: 1, 1, 1.33

Iris: 0, 0, 1

Conjunctivae: 3, 2.33, 2.33

These results indicate that the test item is eye damaging and not reversible after 21 days. According to this result the substance is considered to be classified as eye damaging category 1 (CLP (EC) No 1272/2008).

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Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline study

Justification for selection of eye irritation endpoint:
Guideline and GLP study

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin Irritation

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is not considered to be classified for skin irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 1297/2014.

Eye irritation

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is considered to be classified for eye irritation as Xi, R41 under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.As a result the substance is considered to be classified for eye damage in category 1 under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 1297/2014.