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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
750 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study was conducted in accordance with the standardised guideline OECD 422 under GLP conditions. It was assigned a reliability score of 1 in accordance with the criteria set forth by Klimisch (1997).
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Effect on fertility: via oral route

A combined repeated dose toxicity study with reproduction/developmental toxicity screening test was carried out on the test substance in order to assess the test material in accordance with the standardised guidelines OECD 422 and EPA OPPTS 870.3650 under GLP conditions.

Four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test material at 0, 75, 250 and 750 mg/kg/day in propylene glycol. Males were exposed for 28 days (2 weeks prior to mating, during mating, and up to termination) and females were exposed for 41 to 55 days (2 weeks prior to mating, during mating, during postcoitum and during at least 4 days of lactation).

Animals were evaluated for mortality/viability, clinical signs, functional observations and locomotor activity, body weight and food consumption, clinical pathology, macroscopy at termination, organ weights and histopathology on a selection of tissues and reproduction/developmental parameters.

Under the conditions of this study, the NOAEL for parental repeated dose toxicity was determined to be 75 mg/kg bw/day.

No toxicologically relevant effects on reproductive parameters were noted. The mating, fertility and conception indices, precoital time, and number of corpora lutea and implantation sites were unaffected by treatment.

Under the conditions of this study, no reproductive toxicity was observed up to the highest dose level tested. The NOAEL for reproductive parameters is therefore considered to be 750 mg/kg/day.


Short description of key information:
TOXICITY TO REPRODUCTION
NOAEL 750 mg/kg/day male and female Wistar Han strain rats.

Justification for selection of Effect on fertility via oral route:
Only one study available.

Effects on developmental toxicity

Description of key information
DEVELOPMENTAL TOXICITY / TERATOGENICITY 
NOAEL 75 mg/kg/day Wistar Han strain rats.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
75 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study was conducted in accordance with the standardised guideline OECD 422 under GLP conditions. It was assigned a reliability score of 1 in accordance with the criteria set forth by Klimisch (1997).
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

Effect on developmental toxicity: via oral route

A combined repeated dose toxicity study with reproduction/developmental toxicity screening test was carried out in order to assess the test material in accordance with the standardised guidelines OECD 422 and EPA OPPTS 870.3650 under GLP conditions.

Four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test material at 0, 75, 250 and 750 mg/kg/day in propylene glycol. Males were exposed for 28 days (2 weeks prior to mating, during mating, and up to termination) and females were exposed for 41 to 55 days (2 weeks prior to mating, during mating, during postcoitum and during at least 4 days of lactation).

Animals were evaluated for mortality/viability, clinical signs, functional observations and locomotor activity, body weight and food consumption, clinical pathology, macroscopy at termination, organ weights and histopathology on a selection of tissues and reproduction/developmental parameters.

Under the conditions of this study, the NOAEL for parental repeated dose toxicity was determined to be 75 mg/kg bw/day.

The mean litter size was smaller at 750 mg/kg than controls and higher pup mortality was evident at both 250 and 750 mg/kg. No toxicologically significant changes were noted in any of the remaining developmental parameters investigated in this study (i.e. gestation index and duration, parturition, maternal care and clinical signs, bodyweights and macroscopy of pups).

Under the conditions of this study, the NOAEL for developmental parameters is considered to be 75 mg/kg/day. The test material therefore requires classification in accordance with EU criteria for developmental toxicity as Category 2.


Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) 1272/2008, the test material requires classification for developmental toxicity as Category 2.

Additional information