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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Quality of whole database:
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.
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. No treatment-related changes were noted in any of the reproductive parameters investigated in this study (i.e. mating, fertility and conception indices, precoital time, numbers of corpora lutea and implantation sites, spermatogenic profiling, and histopathological examination of reproductive organs). 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.


Short 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 ferility was found to be greater than 1000 mg/kg bw/day

Justification for selection of Effect on fertility via oral route:
GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Effects on developmental toxicity

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 maternal and developemental toxicity was found to be greater than 1000 mg/kg bw/day (highest dose tested).
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
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 Han 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. 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 maternal 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. No treatment-related changes were noted in any of the developmental parameters investigated in this study (i.e. gestation index and duration, parturition, maternal care and early postnatal pup development consisting of mortality, clinical signs, body weight and macroscopy). Under the conditions of this assay the NOAEL for maternal and developmental toxicity was found to be greater than 1000 mg/kg bw/day.


Justification for selection of Effect on developmental toxicity: via oral route:
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 28 -day repeated dose reproductive and developmental screening 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.

Additional information