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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Oral: OECD 422; 28-day gavage, rats. NOEL >1000 mg/kg (highest dose tested); Reliability = 1

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
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

The objectives of the study were to evaluate the potential toxic effects of the test substance, when administered to rats for 28 days. The test substance, in the vehicle (0.5% carboxymethylcellulose and 0.1% Tween® 80 in deionized water, pH 3.5) was administered orally by gavage once daily to 3 groups of Crl:CD(SD) rats, each group consisting of 10 males and 10 females. Dosage levels were 250, 500, and 1000 mg/kg/day. A concurrent control group of 10 rats/sex received the vehicle on a comparable regimen. Males received a total of 28–29 doses and females received a total of 52 doses. All animals were observed for mortality and morbundity. Clinical observations, body weight, and food consumption, FOB and motor activity data, clinical pathology, macroscopic and microscopic (control and high dose only) examinations were performed. All F0 males and females in the 250, 500, and 1000 mg/kg/day groups survived to the scheduled necropsies. Two F0 females in the control group were found dead or euthanized in extremis during the study. No test substance-related clinical observations were noted at the daily examinations, detailed physical observations, or approximately 2 hours following dose administration at any dosage level. Mean body weights, body weight gains, and food consumption for F0 males and females at 250, 500, and 1000 mg/kg/day were unaffected by test substance administration throughout the study. No test substance-related effects were noted during the FOB or motor activity evaluations at any dosage level in the F0 generation. There were no test substance-related macroscopic or microscopic findings, or effects on clinical pathology parameters (haematology, coagulation, serum chemistry) and organ weights noted for F0 males and females at any dosage level. There were no test substance-related effects on thyroid hormone values noted for F0 males at any dosage level. Under the conditions of this screening study, no test substance-related effects were noted at any dosage level. Therefore, a dosage level of 1000 mg/kg/day, the highest dosage level evaluated, was considered to be the no-observed-effect level (NOEL) F0 parental systemic toxicity, of the test substance when administered orally by gavage to Crl:CD(SD) rats.

Justification for classification or non-classification

Based on no adverse test substance-related effects at 1000 mg/kg (highest dose tested) in 28-day rat gavage study, the test substance does not need to be classified for repeat dose toxicity according to EU Classification and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.