D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.

Endpoint summary

Description of key information

Glucamide CC was investigated for skin and eye irritation potential in GLP conform studies according to OECD test guidelines 439 (Episkin), 437 (BCOP) and OECD 405 (Draize Test). Based on the results of these studies, Glucamide CC is not irritating to skin but is considered to be a severe eye irritant. 

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Considering animal welfare principles, the skin irritation potential of Glucamide CC was tested in the in vitro Episkin^TMstandard model (OECD TG 439), a reconstituted 3D human epidermis model used as replacement for the in vivo Draize skin irritation test. Based on a relative mean tissue viability of greater 50% at the end of the experiment, Glucamide CC is classified as non-irritant (CLP `no category`).

This finding of lack of irritation is supported by data on the read-across compound Glucamide 24 (Test material E-4194.01, 98%). In a study complying with US EPA FIFRA SubF81-5 (1982), New Zealand White rabbits (2 males, 1 female) were exposed to 0.5 g/animal intact semioccluded for 4 hours with washing followed by observation at 1, 24, 48, 72h and 7 and 14 days.The compound was concluded to be a non-irritant based on erythema and oedema scoring . All effects reversed and there was no staining and no corrosion to the skin.

With regard to potential eye irritancy, Glucamide CC ( 20% w/v in physiological saline) was investigated in the bovine corneal opacity and permeability assay in vitro (BCOP) according to OECD test guideline 437. Based on a mean in vitro irritation score (IVIS) of 33.37, no prediction as to the classification of Glucamide CC concerning eye irritation/corrosion could be made. Subsequent testing in vivo using OECD TG 405, revealed that Glucamide CC has to be considered a severe eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.

Justification for selection of eye irritation endpoint:
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the results of a guideline and GLP compliant OECD TG 439 study (Episkin^TM), no classification of Glucamide CC with regard to skin irritation/corrosion is warranted according to the criteria of the EU Classification, Labelling and Packaging Regulation 1272/2008/EC (CLP).

Based on the results of a guideline and GLP compliant OECD TG 437 study (BCOP), no prediction regarding the classification of Glucamide CC could be made. Subsequent testing in a guideline and GLP conform OECD TG 405 study revealed that Glucamide CC has to be considered to cause severe damage to eyes and thus is classified a category 1 eye irritant according to the criteria of the EU Classification, Labelling and Packaging Regulation 1272/2008/EC (CLP).