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Administrative data

Description of key information

From the available OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and OECD Guideline 405 (Acute Eye Irritation / Corrosion), it is found that the test substance is not corrosive to the rabbit skin/eyes.

Key value for chemical safety assessment

Additional information

Skin irritation

In the available TNO-CIVO (1990) study of validity 4 (only secondary source available) performed according to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion), 0.5 g of test substance in 0.5 g tap water in a small plastic cup (considered as occlusive condition) was applied to the intact skin site (test site preparation not specified) of 3 male New Zealand White rabbits for 4 hours (no data available on observation period and negative control conditions). The skin reaction was evaluated according to the OECD scoring system. While a slight reaction was generally observed 1 hour after treatment (mean erythema score =1.0 and mean edema score = 0.7), no erythema or edema was still present at the 24-72 hours observation time periods.

 

Eye irritation

In the available TNO-CIVO (1990) study of validity 4 (only secondary source available) performed according to the OECD Guideline 405 (Acute Eye Irritation / Corrosion), 0.1 ml (corresponding to 0.065 g) unchanged test substance was applied to the conjunctival sac of each one eye of 3 male New Zealand White rabbits for a treatment duration not specified, while the remaining untreated one probably served as negative control (no data available on observation period and negative control conditions). The ocular reactions were then evaluated according to the OECD scoring system. The only sign of ocular irritation was slight conjunctival (mean 1-hour score of 0.33) and chemosis (mean 1-hour score of 0.33) reactions observed after 1 hour, but was fully reversible within 24 hours after treatment.

 

Respiratory irritation

No data available

Justification for classification or non-classification

Based on the OECD scoring of the skin/eye irritation studies described aboved, there is no need for classification of the test substance for skin/eye irritation according to the EU Dangerous Substance Directive 67/548/EEC and to the CLP Regulation (EU) 1272/2008.