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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

One eye and one skin irritation study were conducted with the test item. In both studies no irritation was observed after 24, 48 and 72 hours. 

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:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

In a primary dermal irritation study (NUMBER), young adult New Zealand White rabbits (3 females) were dermally exposed to 0.5 g of moistened test material (NAME) for 4 hours under semiocclusive conditions. Animals then were observed 1, 24, 48 and 72 hours, as well as 7 days after treatment. No erythema and no edema irritation were observed within the course of the observation period. The cumulative irritation score was 0.00 based on the DRAIZE scheme indicating no irritant potential. In this study, NAME is not a dermal irritant.

Eye irritation:

In a primary eye irritation study (NUMBER) 0.1 g of NAME was instilled into the conjunctival sac of the left eye of young adult New Zealand White rabbits (3 females). Animals then were observed 1, 24, 48 and 72 hours, as well as 7 days after treatment. No signs of irritation were observed at the cornea or iris within the course of the observation period. The cumulative irritation score of NAME was 0.00 based on the DRAIZE scheme indicating no irritant potential. In this study, NAME is not an eye irritant.

Justification for classification or non-classification

Skin irritation:

Based on the results obtained the cumulative irritation score of NAME was 0.00 according to the DRAIZE scheme indicating no irritant potential. Therefore, NAME is classified as not irritating according to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP.

Eye irritation:

Based on the results obtained the cumulative irritation score of NAME was 0.00 according to the DRAIZE scheme indicating no irritant potential. Therefore, NAME is classified as not irritating according to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP.