Registration Dossier
Registration Dossier
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EC number: 214-711-0 | CAS number: 1189-08-8
Endpoint summary
Administrative data
Description of key information
Oral administration:
A combination study of OECD 422/ 408 is ongoing with 1,3 -BDDMA. The results will be reported as soon as they will become available.
The current DNEL is based on available results with 1,3-butanediol (Reuzel, 1978) and will be updated as soon as the new data will become available.
Inhalation:
Based on physico-chemical data, the inhalation of the substance is very unlikely. Furthermore, spray-application are excluded.
Dermal administration:
Based on physico-chemical data, the dermal absorption of the substance is very low.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- OECD 422 and OECD 408
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- The performance of the OECD 422/408 is in delay and is currently being conducted. The results will be available presumably in Q3/2023. The results will be included in the assessment in the next dossier update.
- Principles of method if other than guideline:
- Combination study of OECD 422 and 408
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 6 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
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
Based on the available data, 1,3-BDDMA does not need to be classified for repeated dose toxicity according to the criteria given in regulation (EC) 1272/2008. Thus, no labelling is required.
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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