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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In an 28-day toxicity study there were no adverse effects observed.

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

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 a subacute 28-day toxicity study performed according to OECD 407 guideline and GLP principles, MDI/CHA 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 NOEL 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

Based on the available data, MDI/CHA does not have to be classified according to Regulation (EC) No 1272/2008 and its amendments.