Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation.

Serious eye damage.

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 (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was performed to assess the irritancy potential of the test item following a single, 4-hour, semi-occluded application to the intact rabbit skin folllowing the OECD guideline 404 (1981). Very slight erythema was noted at two treated skin sites one hour after patch removal. Very slight to well-defined erythema was noted at all treated skin sites at the 24-hour observation with well-defined erythema at the 48-hour observation and very slight to well-defined erythema at the 72-hour observation. Very slight to slight oedema was noted at all treated skin sites at the 24 and 48-hour observations with very slight oedema at the 72-hour observation. Signs of erythema and oedema were all reversible within 7 days.

Crust formation or desquamation were noted at all treated skin sites seven days after treatment.

Based on the effects at 7 days after treatment, the test substance was considered as irritant to skin.

A study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit, following OECD guideline 405(1987).

A single instillation of the test material to the non-irrigated eye of one rabbit produced areas of translucent corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were corneal sloughing, a dulling of the normal lustre of the corneal surface and petechial haemorrhage or a white appearance of the nictitating membrane.The test item was considered to cause serious eye damage.

Justification for classification or non-classification

The mean scores for erythema and edema in 3/3 treated animals at 24, 48 and 72 h time points were below the threshold value for classification as skin irritant of 2.3 and were all reversible within 7 days. However, crust formation or desquamation were noted 7 days after treatment. No observation 14 days after treatment was done. Based on effects at 7 days, the test item is classified for skin irritation in category 2 (H315: Causes skin irritation) according to the CLP Regulation (EC 1272/2008).

Based on irreversible damages, the test item is classified for serious eye damage in category 1 (H318: Causes serious eye damage) according to the CLP Regulation (EC 1272/2008).