Registration Dossier
Registration Dossier
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EC number: 617-328-0 | CAS number: 82391-37-5
Endpoint summary
Administrative data
Description of key information
In accordance with Annex VIII of REACH, a study to address information requirement 8.6.1 (short-term repeated dose toxicity) does not need to be conducted because relevant human exposure can be excluded in accordance with REACH Annex XI Section 3.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because relevant human exposure can be excluded as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- In accordance with Annex VIII of REACH, a study to address information requirement 8.6.1 (short-term repeated dose toxicity) does not need to be conducted because relevant human exposure can be excluded in accordance with REACH Annex XI Section 3.
Indeed, the available toxicokinetic information indicates that the bioavailability of enzymes is low due to the fact that no significant absorption can be expected through the respiratory and/or gastrointestinal tract and/or through the skin.
Furthermore, exposure to enzymes will be limited because of the DMEL (derived minimum exposure levels) to prevent respiratory allergy (supported by exposure scenarios and DMEL values included in the CSR). Respiratory allergy is generally considered to be the only human health hazard of enzymes indicating that this is the most sensitive endpoint considering enzyme toxicity. Concentrations that are not expected to result in respiratory allergy will not result in any other toxic effect.
Finally, a short-term repeated dose toxicity study is not conducted on animal welfare grounds since it would not represent an ethical or justified use of animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to specific target organ toxicity following repeated exposure.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
