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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A subchronic feeding study was performed on male and female Wistar rats.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
81.4 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
scinetifically acceptable and sufficient documented for evaluation.
System:
other: body weight gain

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 a feeding study 15 male and 15 female rats received the test substance for 3 month in doses of 0 (control), 100, 1000 or 10000 ppm (male rats: 0, 8.34, 81.4, or 849,28 mg/kg bw/d; female rats: 0, 12.28, 121,32, or 1245,05 mg/kg bw/d). Animals were examined for mortality, body weight gain and clinical signs. A clinical-chemical, heamatological and urinalysis was peformed. A necropsy with a histopathological exmaination was done at the end of the study. Appearence and behaviour were unaffected. None of the animals died. No adverse effects were seen in haematology, clinical-chemistry and urinalysis. The body weight gain of the male rats was slightly retarded. In this context, the heart and testis weights of male rats were lower, but no histopathological effects were detected. Therefore these findings were regarded as toxicological not relevant. Pathology and histopathology were unobtrusive.

The NOAEL for male rats was 1000 ppm = 81.40 mg/kg bw/d and the NOAEL for female rats was 10000 ppm = 1245.05 mg/kg bw/d (highest applied dose).

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.