Registration Dossier
Registration Dossier
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EC number: 203-569-5 | CAS number: 108-29-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to Regulation (EC) No 1272/2008 Annex XI, existing data on human health from experiments not carried out according to GLP or the test methods referred to in Article 13(3) shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met:
(1) Data are adequate for the purpose of classification and labelling and/or risk assessment
(2) Data adequately and reliably cover of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3)
(3) The exposure duration is comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter
(4) An adequate and reliable documentation of the study is provided.
The available skin sensitisation study performed with human volunteers described in section 7.10.4 is considered to meet these requirements. Thus, further in vitro testing is waived as adequate human data are available.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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