Registration Dossier
Registration Dossier
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EC number: 208-993-4 | CAS number: 551-16-6
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 test material was considered to be a non sensitiser under the conditions of the test. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Migrated from Short description of key information:
Skin sensitisation was investigated according OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) and EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Previous literature on skin sensitization have concluded that in rabbits treated with the standard 6- Aminopenicillanic Acid (6-APA) produced high levels of penicilloyl-specific antibodies, but that after purification processes to remove high molecular weight impurities, 6-APA failed to induce these levels of antibodies in rabbits. A similar situation was found with Ampicillin prepared from original processed 6-APA, when injected in rabbits, high levels of penicilloyl specific antibody were found then when the Ampicillin was prepared from 6-APA specially purified by complex adsorption processes to remove protein impurities. Occupational asthma (in section 7.10.4) seen is an old case study with 6-APA, is probably due to the impurities, however since then a change in the manufacturing process of antibiotics has been introduced to remove protein impurities (high molecular weight). This process is said to lower the immunogenicity potential and hence suggest that 6-APA is not any more a respiratory sensitizer. Further evidence to suggest that 6-APA is not a respiratory sensitiser is the negative result in the LLNA assay in section 7.4.1.
References:
Knudsen ET, Dewdney JM & Trafford JAP. Reduction in Incidence of Ampicillin Rash by Purification of Ampicillian.British Medical Journal.(1970).1:169-471. (Reference Attached) http://www.wikipatents.com/US-Patent-3770584/pronase-purification
Justification for classification or non-classification
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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