Registration Dossier

Administrative data

Description of key information

The skin irritation/corrosion study was performed according to OECD Guideline 404 and GLP principles and the eye irritation/corrosion study was performed according to OECD Guideline 405 and GLP principles. The substance was considered not skin and not eye 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

Skin:

In a skin irritation study, performed according to OECD, EC, EPA and JMAFF test guidelines, three rabbits were exposed to 0.5 ml of Radiagreen RA by application onto the clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours and 7 days after exposure. Exposure to Radiagreen RA resulted in well-defined erythema and moderate oedema in the treated skin areas. Scaliness was observed in one animal after 72 hours. The skin irritation had resolved within 72 hours after exposure in one animal and within 7 days after exposure in the other two animals. Therefore, Radiagreen RA is considered to be not skin irritating.

Eye:

In a eye irritation study, performed according to OECD, EC, EPA and JMAFF test guidelines, three rabbits were exposed to 0.1 ml of Radiagreen RA by instillation into the eye. Observations were made 1, 24, 48 and 72 hours after instillation. Installation of the substance resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed in one animal and had resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 72 hours. Therefore, Radiagreen RA is considered not eye irritating.

Justification for classification or non-classification

Based on the study information, the substance is not classified as skin/eye irritant according to CLP Regulation (EC) No. 1272/2008.