Registration Dossier

Administrative data

Description of key information

The results indicate that the test substance does not have a significant irritation potential on skin and eye. Thus, the test substance can be regarded as non irritating to the skin and eye.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Key study:

The irritant/corrosive potential of the test substance was studied on the skin and eye of the rabbit in accordance with OECD guideline 404 and 405. Whilst considering OECD Interpretation Guides results were interpreted in conjunction with the nature, intensity and reversibility of responses observed. The irritation was scored accordig to Draize after 1 h, 24 h, 48 h, 72 h and 7 d.

- Regarding skin irrition: All three animals showed irritation indices of 0 for both erythema/eschar formation and oedema formation.

- Regarding eye irritation: All three animals showed irritation indices of 0 for both cornea, iris conjuctivae and epithelial defects. Irritation indices for aqueous humour and discharge were 2 and 3, respectively after 1 hour. But these signs were fully reversible after 24 h.

The results indicate that the test substance does not have a significant irritation potential on skin and eye. Thus, the test substance can be regarded as non irritating to the skin and eye.

Supporting study:

In this skin and eye irritation study using rabbits the test substance was reported to be non irritating.


Justification for selection of skin irritation / corrosion endpoint:
OECD and guideline study

Justification for selection of eye irritation endpoint:
OECD and guideline study

Justification for classification or non-classification

Based on the results the test substance does not have to be classified as irritating to skin and/or eye according to EU Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008.