Registration Dossier

Administrative data

Description of key information

Skin irritation = Not irritating, rabbit, OECD 404, EU method B.4, Korenaga et al. (1983) & Bullock et al. (1982)
Eye irritation = Not irritating, rabbit, OECD 405, EU method B.5, Korenaga et al. (1983) & Bullock et al. (1982)

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

Two studies investigating the skin irritation potential of the test material were available. Both studies were conducted following a methodology equivalent to standardised guidelines OECD 404 and EU Method B.4. During the studies, six rabbits received 0.5 mL test material to two intact and two abraded sites for four hours (Korenaga et al., 1983) and twenty four hours (Bullock et al., 1982). All animals were assessed for the following 7 days for any signs of skin irritation. In the study reported by Korenaga et al., the test material caused no irritation, either to intact or abraded sites, but did stain the skin of all animals yellow. The primary irritation score was 0. The test material was subsequently concluded to be not irritating to the skin. In the study reported by Bullock et al., the test material caused well-defined to moderate erythema and very slight to moderate edema through 72 hours after treatment. At seven days after treatment, one animal had well defined erythema, and five out of six animals had dry and cracked skin. The overall irritation score was 4.3. The test material was subsequently concluded to be not irritating to the skin

 

EYE

Two studies investigating the eye irritation potential of the test material were available. Both studies were conducted following a methodology equivalent to standardised guidelines OECD 405 and EU Method B.5. During the studies 0.1 mL test material was applied into one eye of each of nine rabbits, the other eye remained untreated and served as a control. The treated and control eyes of three of the animals were rinsed with water 30 seconds after treatment. All animals were assessed for up to 7 days to determine the grade of ocular reaction. In the study reported by Korenaga et al., neither corneal opacity nor iritis was observed. The test material caused very slight to severe conjunctival irritation in all treated-unrinsed eyes one hour after dosing. Moderate conjunctival irritation was observed in all treated-rinsed eyes one hour after dosing. Both treated-unrinsed and treated-rinsed eyes appeared normal by the 72 hour reading. In consideration of the ocular effects observed it was concluded that the test material does not require classification as an eye irritant. In the study reported by Bullock et al., neither corneal opacity nor iritis was observed. The test material caused slight conjunctival irritation in treated-unrinsed animals, and two treated-rinsed animals, one hour after dosing. Both treated-unrinsed and treated-rinsed eyes appeared normal by the 24 hour reading. In consideration of the ocular effects observed it was concluded that the test material does not require classification as an eye irritant.

 

All studies presented to assess the irritation potential of the test material were performed in line with GLP and followed methodologies equivalent to those outlined in accepted standardised guidelines with a high standard of reporting. All 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 the conclusion for both skin irritation, and eye irritation, not irritating, was taken forward for risk assessment.


Justification for selection of skin irritation / corrosion endpoint:
Two studies were available and both were considered as key studies.

Justification for selection of eye irritation endpoint:
Two studies were available and both were considered as key studies.

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 is classified 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.