Registration Dossier
Registration Dossier
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EC number: 210-817-6 | CAS number: 623-84-7
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:
Positive reactions were obtained in two out of 19 animals, but only 24 hours after removal of the dressings. After 48 hours no positive reactions were observed. A sensibilization rate of 10.5% was calculated. Therefore, it can be concluded that DOWANOL* PGDA induces no delayed contact hypersensitivity in the guinea pig.
Migrated from Short description of key information:
A GLP study according to OECD guideline 406 (Buehler method) has been conducted with PGDA.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the negative result of the skin sensitization study PGDA is not expected to be a respiratory sensitizer.
Migrated from Short description of key information:
No data on respiratory sensitization is available for PGDA.
Justification for classification or non-classification
Only 2 out of 19 animals showed a positive reaction after 24 hours. A sensitization rate of 10.5% was calculated. According to EU criteria for classification and labelling requirements for dangerous substances as laid down in Annex VI of the EEC Council Directive 671548lEEC (amended by Directive 83/467/EEC) and according to GHS/CLP, PGDA is not classified as a sensitiser.
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