Registration Dossier

Administrative data

Description of key information

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

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by semi-occlusive application of 0.5 mL to the intact flank of each of three New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 -60 minutes, 24, 48 and 72 hours after removal of the patch.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00 and the mean oedema score was 0.00 for all animals.

The application of the test item to the skin resulted in no signs of irritation. The test item is considered to be “not irritating” to rabbit skin.

With reference the reported scores and the absence of any signs of irritation during the whole study period the test item does not need to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. All individual mean scores were 0.00 for all three animals.

The instillation of test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae, discharge and chemosis, which were mostly present at the 1-hour reading. 24 hours after the treatment, no signs of eye irritation were observed in the conjunctivae of the animals. Furthermore, no abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

With reference to the reported scores and observations the test item does not need to be classified as irritant to the rabbit eye according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).


Justification for selection of skin irritation / corrosion endpoint:
Guideline study, performed according to the principles of GLP

Justification for selection of eye irritation endpoint:
Guideline study, performed according to the principles of GLP

Justification for classification or non-classification

With reference to the reported scores and observations the test item does neither need to be classified as irritant to the rabbit eye nor as irritant to the rabbit skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).