Registration Dossier
Registration Dossier
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EC number: 248-003-8 | CAS number: 26787-78-0
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:
SKIN SENSITISATION (OCCUPATIONAL EXPOSURE): According to the available evidence showing that amoxicillin can lead to skin sensitisation based on human experience and also based on the evidence from chemical structure related substances (penicillins), the substance amoxicillin is proposed to be classified as skin sensitiser.
Please refer to Section 7.10 for more information.
Migrated from Short description of key information:
Based on available data on human reports, the substance is determined to be skin sensitizer.
Justification for selection of skin sensitisation endpoint:
According to Column 2 of REACH Annex VII, the study does not need to be conducted since the available information indicates that the substance should be classified for skin sensitization (see Section 7.10.4 Sensitization data (Humans)).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
RESPIRATORY SENSITISATION (OCCUPATIONAL EXPOSURE): According to the available evidence showing that amoxicillin can lead to specific respiratory hypersensitivity based on human experience and also based on the evidence from chemical structure related substances known to cause respiratory hypersensitivity (penicillins), the substance amoxicillin is proposed to be classified as respiratory sensitiser.
Please refer to Section 7.10 for more information.
Migrated from Short description of key information:
Based on available data on human reports, the substance is determined to be respiratory sensitizer.
Justification for selection of respiratory sensitisation endpoint:
According to Column 2 of REACH Annex VII, the study does not need to be conducted since the available information indicates that the substance should be classified for skin sensitization (see Section 7.10.4 Sensitization data (Humans)).
Justification for classification or non-classification
Based on available data, the substance is classified as respiratory sensitizer and skin sensitizer category 1 according to CLP Regulation (EC) no. 1272/2008.
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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