4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile

Endpoint summary

Description of key information

Based on skin and eye irritation and corrosion studies, performed in vitro and in vivo, it can be concluded that the test substance is not corrosive or irritating to the skin and eye.

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

The corrosive potential of the test substance was determined in an in vitro EpiDerm™ Corrosivity-Test (BASF 2008) and in a HET-CAM in vitro corrosion test (BASF 2008). From both test it could be concluded that the test substance is not corrosive to the skin and eye. To test the irritating properties of the test substance two in vivo experiments have been performed.

The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (compiant with GLP), by a single topical application of an amount of 0.5 g of the test substance for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm covered with semiocclusive dressing (BASF 2008). After removal of the patch, the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch and approximately 1, 24, 48, and 72 hours after removal. Slight or moderate erythema was observed in all animals up to 1 hour after removal of the patch. The cutaneous reactions were reversible in all animals within 24 hours after removal. The average score (24 to 72 hours) for irritation was calculated to be 0 for erythema and for edema. It was concluded that the test substance was not irritating to the skin.

In an OECD 405 guideline study performed in accordance with GLP, the potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 37 mg) of the test substance to one eye of three White New Zealand rabbits (BASF 2008). 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. The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris, chemosis, and 0.4 for conjunctival redness (in which three animals had a score of 0.7, 0.3 and 0.3 respectively). The findings were reversible within 72 hours after application. It was concluded that the test substance was not irritating to the eye.

Justification for selection of skin irritation / corrosion endpoint:
Two studies were performed. At first an EpiDerm™ Corrosivity-Test. Due to the non-corrosive conclusion an OECD 404 in vivo study was performed. The latter study is chosen as key study.

Justification for selection of eye irritation endpoint:
Two studies were performed. At first a HET-CAM in vitro corrosion test. Due to the non-corrosive conclusion an OECD 405 in vivo study was performed. The latter study is chosen as key study.

Justification for classification or non-classification

Based on the results observed in the skin and eye irritation and corrosion tests, classification for skin irritation / corrosion and eye irritation is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.