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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
20 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 adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
In the oral 90 days test a NOAEL of 20 mg/kg bw/d was determined. At the higher test doses (200 and 2000 mg/kg be/d) several adverse effects was observed. Signs were ALT and AST levels, increased relative liver weight (associated with centrolobular hypertrophy), increased spleen weight, histiocytosis of the mesenteric lymph nodes and liver, necrosis, inflammation and hypertrophy of the liver)

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
In a 28 days test on rats via the dermal route a NOAEL of 1 g/kg bw/d was found. At this dose no clinical signs, no deaths and no effects on heamatological, biochemical and urinanalysis parameters were seen. The necropsy did not reveal any abnormalities. The adrenal gland weight was slightly increased but did not demonstrate treatment related changes.

Justification for classification or non-classification