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Endpoint summary

Description of key information

The test substance does not show corrosive potential in the EpiDerm™ skin corrosivity test under the test conditions chosen (BASF SE, 2003), but skin irritation potential is observed in the acute dermal irritation/corrosion test in rabbits (BASF SE; 2003).
The test substance did not produce changes indicative for severe eye irritation in the HET-CAM test (BASF SE, 2003) and also no eye irritation potential was observed in the acute eye irritation test in rabbits (BASF SE, 2003).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation:

In a GLP-compliant study, according to OECD guideline 431, the potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 µL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™) (BASF, 2003). Two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The EpiDerm skin corrosivity test showed that the test substance is not able to directly reduce MTT. Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 99% and after an exposure period of 1 hour 108%. These results do not indicate a corrosive potential of the test substance.

A GLP compliant dermal irritation/corrosion test, according to OECD guideline 404, in White New Zealand rabbits was performed in order to assess the acute skin irritation potential of the test substance (BASF, 2003). An amount of 0.5 mL of the test substance was applied for 4 hours to the intact skin of three rabbits, using a patch of 2.5 x 2.5 cm, covered with semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and then in weekly intervals until day 14. Slight to marked erythema, partly extending beyond the area of exposure and slight edema were observed in the animals during the course of the study. Additionally dryness of the skin and scaling were noted during the observation period. The cutaneous reactions were reversible in two animals within 7 days, while in one animal slight erythema and scaling was still present up to study termination on day 14. The average score (24 to 72 hours) for irritation was calculated to be 2.4 for erythema and 0.3 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test substance shows a skin irritation potential under the test conditions chosen.

Eye irritation:

In a non-GLP non-guidline in vitro study using the chorio-allantoic membrane in incubated hen eggs (HET-CAM test) the test substance did not produce changes indicative for severe eye irritation (BASF, 2003).

In order to further assess the acute eye irritation potential of the test substance a GLP-compliant eye irritation test in rabbits was performed according to the method described in OECD guideline 405 (BASF, 2003). An amount of 0.1 mL of the test substance was applied to one eye of three White New Zealand rabbits. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight or moderate conjunctival redness and slight or severe discharge were observed in the animals during the course of the study. Slight conjunctival chemosis was noted in one animal 24 hours after application only. The ocular reactions were reversible in all animals within 72 hours after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and for iris, 1.0 for conjunctival redness and 0.1 for chemosis. Considering the described ocular reactions as well as the average score for irritation, the test substance does not show an eye irritation potential under the test conditions chosen.

Respiratory irritation:

see acute toxicity: inhalation

Effects on skin irritation/corrosion: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

The test substance needs to be classified as Skin Irrit Cat 2:H315 according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The test substance does not need to be classified for serious eye damage/eye irritation.

For respiratory irritation a classification is required according to Regulation (EC) No 1272/2008, Annex I, as STOT SE 3 "May cause respiratory irritation" (H335).