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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Read-across, NOAEL (28d) >= 1 100 mg/kg bw/d, according to OECD 422, GLP-compliant, rat, 2012, K1 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
short-term repeated dose toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The substance has been registered as part of Metal lakes 2 group, consisting of three similar substances.
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
Effect level:
>= 1 100 CFU/kg bw/day (actual dose received)
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Critical effects observed:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
1 110 mg/kg bw/day
Study duration:

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

Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening study (OECD 422)

The test substance was administered orally via gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg bw/d (test group 0), 110 mg/kg bw/d (test group 1), 330 mg/kg bw/d (test group 2) and 1110 mg/kg bw/d (test group 3). Regarding clinical examinations, no signs of general systemic toxicity were observed in male or female parental animals of all test groups (110, 330 and 1110 mg/kg bw/d) during the entire study.
The duration of treatment covered a 2-week pre-mating and mating period in both sexes, approximately 1 week post-mating in males, and the entire gestation period as well as 4 days of lactation and two weeks thereafter in females.

A detailed clinical observation (DCO) was performed weakly in all animals. Food consumption and body weights of F0 parents were monitored throughout the study. Towards the end of the administration period clinicochemical and hematological examinations as well as urinalyses were performed in 5 animals per sex and group. Additionally, a functional observational battery was performed and motor activity was measured in 5 animals per sex and test group. All F0 parental animals were sacrificed by decapitation, under isoflurane anesthesia, and were assessed by gross pathology. Weights of selected organs were recorded and a histopathological examination was performed.

The pups were sexed and examined for macroscopically evident changes. They were weighed and their viability was recorded. At necropsy, all pups were sacrificed examined macroscopically for external and visceral findings.

No treatment-related, adverse effects were observed up to a dose of 1110 mg/kg bw/d regarding clinical pathology, pathology, fertility and reproductive performance.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. There were no significant toxic effects at doses of less than 300 mg/kg bw upon subacute oral exposure in rats. As a result, the substance is not classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the fifteenth time in Regulation (EC) No. 2020/1182.