Registration Dossier
Registration Dossier
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EC number: 230-991-7 | CAS number: 7397-62-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The potential of Polysolvan O (butyl glycollate, 99.07%) to produce dermal sensitization in guinea pigs was assessed by the Magnusson-Kligman Maximization Test. Twenty animals were intradermally and topically induced. After a rest period, the animals were challenged but due to equivocal challenge scores at all challenge sites treated with the test article, the animals were re-challenged and the same procedures were conducted using a control group consisting of 10 animals, challenged and re-challenged in the same manner as the test article animals.
Re-challenge with 0.5 ml of a 50% w/v dilution of test substance produced no redness to scattered mild redness at 24 hours and no redness to barely perceptible redness at 48 hours after unwrapping in the animals induced with test substance. There were six instances of hyperkeratosis at 24 hours and six instances at 48 hours. No redness to scattered mild redness was noted at 24 hours and no redness to barely perceptible redness at 48 hours in the vehicle and test article irritation control animals similarly re-challenged. There was one instance of exfoliation and two instances of hyperkeratosis at 24 hours and three instances of exfoliation and two instances ofhyperkeratosis at 48 hours. The response incidence was 5% (1/19) in the test article induced animals. The net incidence was 0% (0/19) in the test article induced animals based on the vehicle and test article irritation control challenge scores.
Under the conditions of this study, Polysolvan O (butylglycollate) is not considered to be a dermal sensitizer in guinea pigs. On the basis of the nature of effects observed in this study and according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Migrated from Short description of key information:
Animal data demonstrate that butyl glycollate (Polysolvan O) does not have a sensitizing potential.
Justification for classification or non-classification
Based on the available data, butyl glycollate (Polysolvan O) does not have to be classified as sensitising according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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