Registration Dossier

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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

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 g of substance semi-occlusively for 4 hours. Skin reactions were assessed 1, 24, 48 and 72 hours, 7 and 14 days after exposure.

Exposure to Radialube 7819 resulted in some irritation seen with mean scores at 24 -48 -72 hours calculated for all three animals of 1.7, 2.0 and 2.3 for each animal for erythema and 0.7, 1.0, 2.0 for each animal for edema. Scaliness was observed in one animal at 72 hours after exposure and in another animal at 7 days after exposure. The skin irritation had resolved within 7 days after exposure in two animals and within 14 days after exposure in the other animal. Sticky and dry test substance remnants were present on the

skin on Day 1. No staining of the treated skin by the test substance was observed. Therefore, Radialube 7819 is considered to be not skin irritating according to the CLP Regulation.

Eye:

In an eye irritation study performed according to OECD, EC, EPA and JMAFF test guidelines, three rabbits were exposed to 0.1 ml of substance. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours. Therefore, Radialube 7819 is considered not eye irritating.

Justification for classification or non-classification

Based on the available data, the substance does not have to be classified for skin and eye irritation according to CLP Regulation (EC) No 1272/2008. In addition, no classification for eye irritation according to Directive 67/548/EEC is required. However, for skin irritation the substance should be classified according to Directive 67/548/EEC with Xi 'Irritant' and R38 'Irritating to skin'.