Registration Dossier
Registration Dossier
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EC number: 406-550-1 | CAS number: - MDI
Endpoint summary
Administrative data
Description of key information
Repeated dose oral (OECD 407): NOAEL (males/females): >=1000 mg/kg bw/day, the highest dose tested
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- For repeated dose toxicity one repeated dose toxicity study is available, conducted according to OECD guideline 407 in compliance with GLP, resulting in adequate information for the endpoint.
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
In this subacute 28-day toxicity study performed according to OECD 407 guideline and GLP principles, MDI/CHA/ODA/DCHA was administered daily by gavage to SPF-bred Wistar rats to 0, 50, 200 and 1000 mg/kg bw/day.
There were no changes in clinical appearance, body weights, food consumption, ophthalmoscopic examination, clinical laboratory investigations, macroscopic examination, organ weights and microscopic examination that were considered to be an effect of treatment.
Based on the absence of adverse effects at 1000 mg/kg bw/day, the NOAEL for males and females in this study is at least 1000 mg/kg bw/day, the highest dose tested.
Justification for classification or non-classification
The NOAEL of the substance is 1000 mg/kg bw/day which is above the classification and labelling limits.
Therefore, classification of the substance is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (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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