Registration Dossier

Administrative data

Description of key information

The substance caused slight transient irritating properties to rabbit skin and eyes as investigated in GLP and OECD 404 and 405 compliant studies. The effects are so mild that there is no need for classification and labelling.

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

A GLP conform in vivo study was performed to assess the acute dermal irritation or corrosion potential of the test substance in White New Zealand rabbits according to the OECD guideline 404 (Ciba 1992a).

Three rabbits were exposed to 0.5 grams of the test substance that was applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

Exposure to the test substance did not result in edema in the treated skin-areas of the rabbits.

Red-brownish staining of the treated skin by the test substance interfered with scoring of two animals at the 24h reading. The third animal showed slight erythema (grade 1 of 4) at the 24, 48 and 72h readings, which resolved within 7 days.

 

To assess the acute eye irritation or corrosion potential of the test substance in vivo a GLP conform eye irritation test in White New Zealand rabbits was performed according to the method described in OECD guideline 405 (Ciba 1993). Single samples of approximately 56 mg of the test substance (a volume of 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test substance resulted in slight transient effects on the conjunctivae and iris

. Irritation of the conjunctivae was seen as slight redness and chemosis, which had completely resolved within 48 hours in all animals. Slight iritis healed within 24 hours. No corneal opacity was observed, and investigation of the eyes with hand slit lamp revealed no corneal epithelial damage in any of the animals. Findings are consistent with those of a supporting study (Ciba 1992b).

 

No data is available on respiratory irritation.

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 for skin or eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

 

Classification, Labeling, 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 skin or eye irritation under Regulation (EC) No. 1272/2008.