Registration Dossier

Administrative data

Description of key information

The substance caused transient irritation of the rabbit skin. Very slight to well-defined erythema was observed. Erythema was fully reversible in all animals within 72 hours following termination of exposure. Very slight oedema demonstrated by all animals was fully reversible within 48 hours after the end of exposure. The test item also caused mild conjunctival reactions in 3/3 animals. The effects on the conjunctivae were fully reversible in all animals within 48 hours after instillation.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In a primary dermal irritation study performed pursuant to EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion 92/69/EEC), 0.5 mL of the test article was applied on gauze pads and placed semi-occlusively to the shaved skin of 3 New Zealand White rabbits. Exposure was performed for the duration of 4 hours. At the end of exposure, exposure sites were washed with water. Animals were observed until total reversal of symptoms. Skin changes were scored using the OECD Draize method. Mean Draize scores after 24, 48 and 72 hours were calculated per animal for erythema and oedema and used for assessment of irritation potential. Mean Draize scores after 24, 48 and 72 hours, calculated for animals 1/2/3 were 0.333/1.667/0.667 for erythema and 0.333/0.667/0.667 for oedema. There were no signs of systemic toxicity or ill health in any rabbit during the observation period (Huntingdon Life Sciences Ltd. 1995). This study is reliable and considered suitable for assessment of skin irritation.

Eye Irritation

The eye irritation potential of the test substance was determined according to the EU Method B.5 (Acute Toxicity to Eye Irritation / Corrosion). 0.1 mL of the test article was instilled to the conjunctival sac of one eye of each of 3 New Zealand White rabbits. The other eye was not treated. Eyes were not washed after instillation. After instillation, the examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days afterwards. Scoring was performed using the OECD Draize scoring method. Mean draize scores after 24, 48 and 72 hours were calculated per animal for corneal opacity, iritis, conjunctivae redness and chemosis and used for the assessment of irritation potential. The mean values of the draize scores taken for animal 1/2/3 after 24, 48 and 72 hours were: 0/0/0 for the opacity of the cornea, 0/0/0 for effects on the iris, 0/0.333/0 for redness, and 0/0/0 for chemosis of the conjunctiva (Huntingdon Life Sciences Ltd. 1995). This study is reliable and suitable for assessment of eye irritation.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation 1272/2008. Based on the criteria laid down in Regulation (EC) No.1272/2008 classification for skin and eye irritation is not warranted.