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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Developmental toxicity: Supporting study: The test item seems to have a NOAEL higher than 125 mg/kg bw/day (maximal dose 225 mg/kg on injection days) in rats, based on the number of births and birth defects. However, no conclusion can be drawn due to the insufficient data.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: Test the teratogenic effects of the substance.
- Short description of test conditions: Rats were given the test item for 4 weeks, one week after the beginning of the treatment the breeding started.
- Parameters analysed / observed: Number of births and malformations of the fetuses.
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 3-4 months
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data



Route of administration:
other: Drinking water (oral) and subcutaneous
Vehicle:
physiological saline
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
Treatment in the drinking water daily. Twice a week injection.
Dose / conc.:
125 mg/kg bw/day (nominal)
Remarks:
On injection days the dose was 225 mg/kg/day (nominal)
No. of animals per sex per dose:
8 female rats
Control animals:
yes, concurrent no treatment
Maternal examinations:
Number of births in control and treated groups.
Fetal examinations:
Any visible defects in the fetuses.
Clinical signs:
not specified
Dermal irritation (if dermal study):
not examined
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not specified
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Other effects:
not examined
Number of abortions:
not specified
Pre- and post-implantation loss:
not specified
Total litter losses by resorption:
not specified
Early or late resorptions:
not specified
Dead fetuses:
not specified
Changes in pregnancy duration:
not specified
Changes in number of pregnant:
not specified
Other effects:
not specified
Key result
Dose descriptor:
NOAEL
Effect level:
> 125 mg/kg bw/day (nominal)
Based on:
test mat.
Fetal body weight changes:
no effects observed
Description (incidence and severity):
No significant differences between number of births in the treated group compared to the control group (control: average 10-12 fetuses/female, treated: average 11 fetuses/female).
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
not specified
Changes in litter size and weights:
not specified
Changes in postnatal survival:
not specified
External malformations:
no effects observed
Description (incidence and severity):
No visible birth defects were observed in the fetuses.
Skeletal malformations:
not examined
Visceral malformations:
not examined
Other effects:
not examined
Key result
Dose descriptor:
NOAEL
Effect level:
> 125 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reduction in number of live offspring
external malformations
Conclusions:
The test item seems to have a NOAEL higher than 125 mg/kg bw/day (maximal dose 225 mg/kg on injection days) in rats, based on the number of births and birth defects. However, no conclusion can be drawn due to the insufficient data.
Executive summary:

A study was conducted to assess the teratogenic potential of the test item in rats. Eight Sprague-Dawley rats were treated for four weeks with an aqueous solution of the test item by injection (twice a week) and in drinking water (daily). The injected dose was about 100 mg/kg and the dose in drinking water was about 125 mg/kg, then the days of injection the total dose was 225 mg/kg. The breeding started one week after starting the treatment. No significant differences between the number of births in the treated group compared to the control group (control: average 10-12 fetuses/female, treated: average 11 fetuses/female). No visible birth defects were observed in the fetuses. Under these experimental conditions, the test item seems to have a NOAEL higher than 125 mg/kg bw/day (maximal dose 225 mg/kg on injection days) in rats, based on the number of births and birth defects. However, no conclusion can be drawn due to the insufficient data.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
125 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimish score 3.
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

Developmental toxicity: Supporting study: A study was conducted to assess the teratogenic potential of the test item in rats. Eight Sprague-Dawley rats were treated for four weeks with an aqueous solution of the test item by injection (twice a week) and in drinking water (daily). The injected dose was about 100 mg/kg and the dose in drinking water was about 125 mg/kg, then the days of injection the total dose was 225 mg/kg. The breeding started one week after starting the treatment. No significant differences between the number of births in the treated group compared to the control group (control: average 10-12 fetuses/female, treated: average 11 fetuses/female). No visible birth defects were observed in the fetuses. Under these experimental conditions, the test item seems to have a NOAEL higher than 125 mg/kg bw/day (maximal dose 225 mg/kg on injection days) in rats, based on the number of births and birth defects. However, no conclusion can be drawn due to the insufficient data.

Justification for classification or non-classification

Due to the insufficient data, the test item cannot be classified for toxicity to reproduction according to CLP Regulation (EC) no. 1272/2008.

Additional information