Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation = Not irritating, male rabbit, OECD 404, EU Method B.4, Goldet and Guillot, 1986
Eye irritation = Not irritating, male rabbit, OECD 405, EU Method B.5, Goldet and Guillot, 1986

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 potential of the test material was determined in accordance with standardised guidelines OECD 404 and EU Method B.4. During the study, six rabbits received a single four hour application of 0.5 mL test material and were assessed for the following 72 hours for any signs of skin irritation. Very slight erythema was seen in all animals approximately one and 24 hours after application. Very slight erythema persisted 72 hours after application in two of the animals. Very slight erythema persisted 48 hours application in one animal. There were no other signs of skin irritation noted during the study. No signs of edema were recorded.

Eye

The eye irritation potential of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5. During the study, approximately 0.1 mL test material was instilled into the right conjunctival sac of each of six rabbits; the left eye remained untreated and served as the control. The animals were assessed for up to 72 hours following test material administration to determine the grade of ocular reaction. There were no corneal effects. Conjunctival effects consisted of slight redness and slight chemosis in all animals up to 24 hours after application. In addition, one animal had slight erythema approximately 48 hours after application. In addition, slight iridial effects were noted in all animals 1 hour after instillation and persisted for 24 hours in 4 animals and for 48 hours in 1 animal. All signs of irritation had completely resolved within 72 hours of application.

Both studies presented to assess the irritation and corrosion potential of the test material were performed in line with 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).


Justification for selection of skin irritation / corrosion endpoint:
Only one study is available.

Justification for selection of eye irritation endpoint:
Only one study is available.

Justification for classification or non-classification

Skin

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

Eye

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