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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

No data is available for the target substance. Thus, available data from a structural analogue (chloride salt) was used in a read-across approach. Details on the read-across rational are provided in section 13.

In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) the source substance was administered orally to 10 male and female Sprague-Dawley rats/dose in water by gavage at dose levels of 0, 40, 100, or 250 mg/kg bw/day. Based on the results of the present study, the NOAEL for maternal and reproductive/developmental toxicity was considered to be 250 mg/kg bw/day.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
250 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
Additional information

No data is available for the target substance. Thus, available data from a structural analogue (chloride salt) was used in a read-across approach. Details on the read-across rational are provided in section 13.

In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) the source substance was administered orally to 10 male and female Sprague-Dawley rats/dose in water by gavage at dose levels of 0, 40, 100, or 250 mg/kg bw/day.

There were no treatment-related effects found regarding mortality, clinical signs, neurotoxicity assessment, body weights, food consumption, histopathology, organ weights, haematology and clinical chemistry. Concerning the reproductive parameters, no relevant differences were found in terms of mating performance including the pre-coital interval (number of days paired to sperm positive day), copulatory evidence (the positive identification of mating i.e. the presence of sperm and/or copulation plug in situ or in the cage) or fertility index. All pregnant females had a comparable length of gestation period and gave birth on day 22 post coitum (mean value). An increased incidence of pups loss value (percentage) on day 1 post partum and post natal loss value on day 4 post partum (percentage) was observed in females receiving 250 mg/kg bw/day without any dose-relationship. Sex ratios at birth and on day 4 post partum did not show differences between groups, when calculated as the percentage of males. Similar clinical signs were recorded in control and treated pups during the lactation period. At necropsy, pups of females receiving 250 mg/kg bw/day and sacrificed at termination showed an increased incidence of no milk in stomach. Deceased pups did not show relevant findings both in control and treated groups.

Based on the results of the present study, the NOAEL for maternal and reproductive/developmental toxicity was considered to be 250 mg/kg bw/day.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data from a structural analogue (chloride salt), the target substance does not warrant classification for reproductive toxicity.

Additional information