Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation = Not irritating, male/female rabbit, OECD 404, EU method B.4, EPA OPP 81-5, Gillis 1997
Eye irritation = Not irritating, male/female rabbit, OECD 405, EU method B.5, EPA OPP 81-4, Gillis 1997

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

The skin irritation and corrosion of the test material was determined in accordance with the standardised guidelines OECD 404, EU Method B.4 and EPA OPP 81-5. Six rabbits received a single four hour application of 0.5 g of the test material and were assessed for the following 3 days for any signs of skin irritation.

Very slight erythema was observed in two male and two female animals 1 hour after patch removal and was still seen in one male and two females at the 24 hour observation. All skin reactions were fully reversible within 48 hours. There were no signs of ill-health in any animal during the study and bodyweights were not affected by treatment.

Eye

The eye irritation of the test material was determined in accordance with the standardised guidelines OECD 405, EU Method B.5 and EPA OPP 81-4. Approximately 66 mg of test material was applied into one eye of each of six rabbits, the second eye served as a control. Treated eyes were assessed for up to 10 days to determine the grade of ocular reaction.

Scattered areas of corneal opacity were seen in a total of three animals, one at the 1-hour examination only, one at 1 and 24 hours, and one at 24, 48 and 72 hours. Moderate hyperemia of the iris was noted for five animals, only at the 1-hour reading. Diffuse, crimson-coloured conjunctival redness (scores of 2) was observed in the treated eyes of all animals after 1 hour, and diminished by day 7 to scores of 1 or were clear. Conjunctival redness was clear in all animals by day 10. All animals also exhibited above-normal swelling of the eyelids and nicitating membranes, or obvious swelling with partial eversion of the eyelids, beginning 1 hour after treatment. Conjunctival chemosis was reversed within 48 or 72 hours, or 7 days. All eye reactions were reversed by day 10. There was no mortality, and no remarkable clinical observations. Slight bodyweight losses were noted for one male and two females.

 

Both studies presented to assess the irritation and corrosion potential of the test material were performed in line with GLP and accepted standardised guidelines with a high standard of reporting. Both studies were assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.

The available data are considered to be complete and a conclusion of not irritating, was taken forward for risk assessment for both skin irritation and corrosion and eye irritation.


Justification for selection of skin irritation / corrosion endpoint:
Only one high quality study was available.

Justification for selection of eye irritation endpoint:
Only one high quality study was available.

Justification for classification or non-classification

Skin

In accordance with the criteria for classification as defined in Annex I, Part 3.2, Regulation 1272/2008, the test material does not require classification for skin irritation.

In accordance with criteria for classification as defined by Directive 2001/59/EC, Annex VI, Point 3.2.6.1, the test material does not require classification for skin irritation.

Eye

In accordance with the criteria for classification as defined in Annex I, Part 3.3, Regulation 1272/2008, the test material does not require classification for eye irritation.

In accordance with criteria for classification as defined by Directive 2001/59/EC, Annex VI, Point 3.2.6.2, the test material does not require classification for eye irritation.

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