Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Two studies in rabbits were performed to evaluate irritating or corrosive properties of the test material to skin or eyes (EU guideline B.4 and B.5). Application of the test substance caused slight erythema of the skin, dulling of the cornea and mild conjuctival irritation. All reaction on skin and eyes has resolved within 2 days. Therefore, the substance is considered to be as not-irritating.

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

Procedure and results

Two studies were performed to evaluate irritating or corrosive properties of the test material to skin or eyes. In the first study, three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. A single semi-occlusive application of the test substance to intact rabbit skin for four hours elicited transient very slight dermal reactions (erythema). All reactions had resolved by Day 2.

In a second study, three rabbits were each administered a single ocular dose of 76 mg of the test substance and observed for seven days after instillation. A single instillation of the test material into the eye of the rabbit elicited dulling of the cornea and transient mild conjunctival irritation. All reactions had resolved 2 days after instillation.

There are no data available about irritation of the respiratory system.

Discussion

Application of the test substance caused slight erythema of the skin, dulling of the cornea and mild conjuctival irritation. All reaction on skin and eyes has resolved within 2 days. Therefore, the substance is not considered to be iritating to skin or eyes.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

 

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).