Registration Dossier

Administrative data

Description of key information

Skin irritation was observed in two reliable in vivo studies in the rabbit. Irritation responses were all reversible within the 14 day observation period. The irritation responses were not sufficient for classification under EU CLP Regulation (EC) No. 1272/2008.
No eye irriration was observed in a reliable in vivo study in the rabbit.

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

Skin irritation:

Two reliable studies are available.

In the key study, performed in accordance with EPA guideline OPPTS 870.2500 [Hoff, 2001] three New Zealand White rabbits were dosed dermally with 0.5 mL of the test material to one intact site per rabbit. Semiocclusive wrapping was applied for 4 hours after which the wrapping was removed and the test site washed. Dermal reactions were scored using the Draize method at 60 minutes, 24, 48 and 72 hours and on days 7 and 14 of the observation period. The skin was also evaluated for ulceration, necrosis or evidence of skin destruction. Erythema was barely perceptible at 60 minutes following patch removal, well-defined at 24 and 48 hours, well-defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Edema was barely perceptible at 60 minutes following patch removal, well-defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well-defined on day 7 and absent by day 14. Bodyweights were recorded pre-test and termination. There were no abnormal systemic signs noted during the observation period and body weight changes were normal.

In the supporting study [Costello, 1982] performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act, six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours. Very slight to well-defined erythema and edema formation was observed at the intact and abraded sites of all animals at 24 hours. At 72 hours well-defined to moderate/severe erythema was observed at the intact and abraded sites of all animals and very slight to well-defined edema was observed at intact sites and well-defined to moderate/severe edema was observed at abraded sites of all animals. There was no evidence of reversibility over the limited timeframe of the study.

Eye irritation:

One reliable study is available. In this study [Costello, 1982] performed using a method similar to 16 CFR 1500.42 of the Federal Hazardous Substances Act, 0.1 mL of the undiluted test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale. No irritation was observed in any animal at any observation period.

Justification for classification or non-classification

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

No classification for eye irritation is required in the absence of effects in an in vivo study in the rabbit.