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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: Milli-Q-Water
Details on mating procedure:
the females were housed individually when daily vaginal smear was sperm positive or a copulation plug was observed;
Details on analytical verification of doses or concentrations:
the dose formulations were prepared weekly;
Duration of treatment / exposure:
males treated for 28 days; dams and pups on day 4 post partum; if birth did not occur the dam was sacrified on day 25 post coitum;
Frequency of treatment:
once daily
Remarks:
Doses / Concentrations:
10 ml/kg b.w.
Basis:
actual ingested
No. of animals per sex per dose:
40 males, 10 per group;
40 females, 10 per group
Parental animals: Observations and examinations:
Viability/ Mortality: twice daily; clinical signs; food consumption; body weights;
Litter observations:
litter size, live birth, still birth and gross anomalies; sex ratio; body weights;
Postmortem examinations (parental animals):
males were sacrified after 28 days treatment: damps and pups were sacrified on day 4 post partum; all parent animals and pups were examined macroscopically; for the parent animals, special attention was directed at the organs of the reproductive system.
Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Other effects:
no effects observed
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: based on the discoloration of feces;
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Mortality / viability:
no mortality observed
Description (incidence and severity):
during the first 4 days post partum
Body weight and weight changes:
no effects observed
Description (incidence and severity):
during the first 4 days post partum
no findings during macroscopic examination
Reproductive effects observed:
not specified
Conclusions:
A valid screening study for reprotoxicity (OECD 421) with the stubstance registered is avaliable. All animals survived the scheduled study period. No indices of a general toxicity were observed during the entire study at any dose level. The reproduction and developmental parameters investigated within this study did not give any indication of any test item-related effect. Thus, the NOAEL for general toxicity was determined to be 1000 mg/kg/day , also is the NOAEL for developmental toxicity considered to be 1000mg/kg/day.
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
Quality of whole database:
Study reliability of 1.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A valid screening study for toxicity to reproduction (OECD 421) with the substance registered is available. The substance registered proved to be not toxic to reproduction up to a dose level of 1000 mg/kg/day.

All animals survived the scheduled study period. No test item-related effects on the relevant reproductive data (mating performance, fertility, corpora lutea count, implantation rate and post-implantation loss, duration of gestation, litter size at first litter check or postnatal loss) were observed at any dose level.

Short description of key information:
Substance registered is not reproduction toxic up to a dose level of 1000 mg/kg/day when applied orally.

Justification for selection of Effect on fertility via oral route:
The selected study was performed under GLP and in accordance with OECD TG 421. No other studies are available.

Effects on developmental toxicity

Description of key information
Substance registered is not reproduction toxic up to a dose level of 1000 mg/kg/day when applied orally.
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
Quality of whole database:
GLP guideline study, Klimisch1
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 valid screening study for toxicity to reproduction (OECD 421) performed with the substance registered, is available. The substance registered proved to be not toxic to reproduction up to a dose level of 1000 mg/kg/day when applied orally. No findings were noted in pups at first litter check or during the first 4 days post partum. Pups sex ratio was not affected by the treatment with the test item at any dose level. No effects were observed on pup body weights and body weight gain during the first four days post partum at any dose level. No findings were noted during macroscopic examination of pups at any dose level.


Justification for selection of Effect on developmental toxicity: via oral route:
The selected study was performed under GLP and in accordance with OECD TG 421. No other studies are available.

Justification for classification or non-classification

The registered substance proved to be not toxic to reproduction up to a dose level of 1000 mg/kg bw/d when orally applied, thus no classification of the test item is required.

Additional information