Registration Dossier
Registration Dossier
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EC number: 204-557-2 | CAS number: 122-60-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Phenylglycidyl ether is classified as a category 1 skin sensitiser in accordance with Regulation (EC) No 1272/2008. There is evidence that the substance leads to sensitisation in humans (see supporting studies) and there are positive results from the guinea-pig maximisation test (see key study).
Using the approach for categorising potency based on a guinea pog maximisation test (key study for this endpoint) phenylglycidyl ether is considered a strong sensitiser.
Migrated from Short description of key information:
The results of the guinea-pig maximisation test indicate that phenylglycidyl ether is a skin sensitiser, with 100 % of animals eliciting a positive response to a 0.83 % (w/v) challenge application following an intradermal induction of 0.55 % (w/v) and a topical induction of 0.83 % (w/v) (day 7). The topical applications were made on an 8 square centimetre area of the animals.
In accordance with ECHA Guidance in Information Requirements and Chemical Safety Assessment, Chapter R8, if the results of a guinea pig maximisation test show that with an intradermal induction concentration of 0.1 - 1% is followed by an incidence of sensitisation ≥ 60% then the substance is considered a strong sensitiser. Phenylglycidyl ether is therefore considered to be a strong sensitiser.
There are also a number of supporting studies indicating that phenylglycidyl ether elicits skin sensitisation in humans exposed to this substance in occupational environments.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no data available to indicate that phenylglycidyl ether is a respiratory sensitiser.
Migrated from Short description of key information:
There are no data available for respiratory sensitisation for phenylglycidyl ether.
Justification for classification or non-classification
Phenylglycidyl ether is classified as a strong skin sensitiser (category 1) in accordance with Regulation (EC) No 1272/2008. There is evidence that the substance leads to sensitisation in humans (see supporting studies) and there are positive results from the guinea-pig maximisation test (see key study). This classification is in agreement with the harmonised scheme for classification and labelling in Regulation EC 1272/2008 (index number 603 -067 -00 -X).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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