Amines, C12-18-alkyl, reaction products with acrylic acid, sodium salts

Endpoint summary

Description of key information

- Skin irritation/corrosion: An in vivo study was available on the submitted substance itself, as a commercial aqueous solution at 30%, allowing to set a Specific Concentration Limit of 30% for skin irritation. An in vitro skin irritation study available on an analogue showed irritation effects sufficient for the classification of the pure substance.
- Eye irritation: An in vivo study was available on the submitted substance itself, as a commercial aqueous solution at 30%, allowing to set a Specific Concentration Limit of 30% for eye irritation. An in vivo eye irritation study available on an analogue showed persistence of ocular effects at the end of the observation period, sufficient for classification as a pure substance.

- Respiratory irritation: no study available.

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

Experimental data on coco-iminodipropionate and its close structural analogue lauro-iminodipropionate were all taken into account in a weight-of-evidence approach.

- Skin irritation/corrosion:

. An in vivo skin irritation study (OECD guideline 404) using the submitted substance itself was available, showing the absence of skin irritation at its use concentration (30%). This study allows to set a Specific Concentration Limit at 30% for skin irritation.

Different studies using a structural analogue with Klimisch reliability 2 were available:

. An in vitro irritation study (REMM, 2013) and an in vivo study conducted on the same analogue substance were used for this endpoint. The in vitro study was conducted according to OECD guideline 439 and in compliance with GLP. Based on the observed results and applying the evaluation criteria for this test, it was concluded that sodium lauriminodipropionate displays a skin irritation potential in the Epiderm TM skin irritation test under the test conditions applied. The results of in vivo data on lower test concentrations of the same analogue substance showed slight or mild irritation illustrating the potential of the pure test substance to be a skin irritant.

. An in vitro corrosion study (OECD guideline 439) on the same test substance came out negative.

Based on the results of these studies on the lauro- analogue, in a precautionary approach, the test substance as pure, or above the Specific Concentration Limit of 30%, is considered to be irritating to the skin, and classified accordingly.

- Eye irritation:

. An in vivo eye irritation study (OECD guideline 405) using the submitted substance itself was available, showing eye irritation (slight corneal effects and conjunctival redness, reversible within 14 days) at its use concentration (30%). This study allows to set a Specific Concentration Limit at 30% for eye irritation versus corrosion.

Two in vivo studies using a structural analogue were available:

. An in vivo study in rabbits (SHAP, 1982) using a low concentration of the test item (16% solids) was used for this endpoint. This study was performed similarly to the OECD No. 405 test guideline. Findings included corneal opacity and conjunctival erythema and discharge. These effects did not fully reverse within the observation period of 7 days. The other study was of unassignable reliability.

Considering the persistence of eye damage at the end of the observation period (7 days) and the low concentration tested, the pure substance, in a precautionary approach, is considered as a severe eye irritant and classified accordingly above the Specific Concentration Limit of 30%. Below or at the Specific Concentration Limit, based on the in vivo study on the submitted substance in solution, it is considered as an eye irritant and classified accordingly.

- Respiratory irritation:

No data was available.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

- Skin irritation/corrosion:

Mainly based on the in vitro results on a direct analogue, in a precautionary approach, disodium cocoiminodipropionate is classified as irritating to the skin into category 2, H315 according to the Regulation (EC) 1272/2008 (CLP) and as Xi; R38 according to the Directive 67/548/EEC above the Specific Concentration Limit of 30%. At and below this concentration limit, including the use concentration of 30%, the substance is considered not to be irritating, based on in vivo results.

- Eye irritation:

Based on the in vivo data on a direct analogue, disodium cocoiminodipropionate is classified as severely irritating to eyes into category 1, H318 according to the Regulation (EC) 1272/2008 (CLP) and as Xi; R41 according to the Directive 67/548/EEC above the Specific Concentration Limit of 30%. At and below this concentration limit, including the use concentration of 30%, the substance is classified as irritating to eyes into category 2, H319 according to the Regulation (EC) 1272/2008 (CLP) and as Xi; R36 according to the Directive 67/548/EEC, based on in vivo results.

- Respiratory irritation:

No classification is possible based on lack of data.