Registration Dossier

Administrative data

Description of key information

No studies on the EC substance [940-223-9] itself are available. A read-across approach using the very close structural analogue [938-147-6] Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine (Public name: Sodium cocoyl glycinate (SCG)) as source substance was chosen.
The source substance was tested for skin and eye irritation in accepted in vitro and in vivo OECD methods using both, the source substance (active content 67.9%) as well as a typically aqueous solution of the source substance as placed on the market (concentration typically ca. 25%). Using the EPISKIN-Standard Model (EPISKIN-SMTM), a reconstituted three-dimensional human epidermis model according to OECD guideline 439, the source substance is considered to be not irritating to skin. Also the aqueous solution as tested in an OECD 404 study was not irritating to skin.
With regard to eye irritation testing of the source substance in the BCOP assay according to OECD 437 revealed severely irritating effects. On the contrary, when tested as aqueous solution with an active content of approximately 25% according to OECD guideline 405 in rabbits, slight to moderate irritative effects were noted which, however, had been reversible within the observation period. The aqueous solution of the source substance (approx. 25% active) therefore is considered to be irritating to eyes whereas the source susbatnce with an active content of 67.9% has shown severly irritating effects.
Based on the justified read-across these endpoint data for the source substance are also taken for the target substance.

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

No studies on the EC substance [940-223-9] itself are available. A read-across approach using the very close structural analogue [938-147-6] Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine (Public name: Sodium cocoyl glycinate (SCG)) as source substance was chosen.

The source molecule was tested for skin and eye irritation in accepted in vitro and in vivo OECD methods using both, the source substance as well as a typically aqueous solution of the source substance as placed on the market. Using the EPISKIN-Standard Model (EPISKIN-SMTM), a reconstituted three-dimensional human epidermis model according to OECD guideline 439, the registered UVCB substance (active content 67.9%) exhibited viability indices not different from controls. Based hereupon, the registered substance was considered to be not a skin irritant. This finding is supported by an in vivo skin irritation test with an aqueous solution of the registered UVCB substance (active content glycinates approximately 25%) according to OECD 404 in rabbits. Following a 4 hour exposure period no significant irritative effects were observed. Thus, it can be concluded that the registered substance is not irritating to skin.

With regard to potential eye irritancy, the registered substance was investigated with an active content of 67.9% and in form of an aqueous solution of the substance as put on the market with an active glycinate content of approximately 25%. In the in vitro `bovine corneal opacity and permeability test` (BCOP), the registered UVCB substance was shown to be severely irritating to eyes.

Testing of the registered UVCB substance in form of an aqueous solution as it is put on the market (active content glycinates of approximately 25%) in the OECD 405 test in rabbits, revealed slight to moderate irritative effects which, however, had been fully reversible within the subsequent observation period. Based on these results, the aqueous solution of the registered substance with an active content glycinates of approximately 25% has to be classified as irritant to eyes whereas the pure UVCB with an active content glycinates of 67.9% has to be classified as severely irritating to eyes.

Based on the justified read-across these endpoint data for the source substance are also taken for the target substance.


Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the available data, the registered UVCB substance with an active content of approximately 65% has to be classified as severely irritating to eyes (R41 according to DSD; category 1 according to UN GHS and EU CLP). No classification is indicated with regard to skin irritation/corrosion.

This classification is also taken for the target substance.