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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422 and GLP compliant) was performed and the NOAEL for repeated dose toxicity was found to be greater than 1000 mg/kg bw/day (highest dose tested).

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

A combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD 422 and in compliance with GLP. The test substance was administered by daily oral gavage to male and female Wistar rats at dose levels of 100, 300 and 1000 mg/kg bw/day (10 rats/sex/dose level). Concurrent controls (10 rats/sex) received the vehicle, 2% aqueous carboxymethyl cellulose, alone. Accuracy, homogeneity and stability of formulations were demonstrated by analyses. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 31 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 41-55 days). No parental toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day) as evidenced by the absence of clinical signs of toxicity or adverse changes in functional observational results, body weight (gain), food consumption, haematology and clinical chemistry parameters, organ weights, macroscopic findings, and microscopic findings. In addition, no effects on fertility and development were observed. Under the conditions of this assay the NOAEL for repeated dose, fertility and developmental toxicity was found to be greater than 1000 mg/kg bw/day.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Justification for classification or non-classification

Based on the results of the repeated dose toxicity test, the substance does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.