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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
GC
Remarks:
Doses / Concentrations:
50 mg/kg/day
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
100 mg/kg/day
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
200 mg/kg/day
Basis:
nominal in diet
No. of animals per sex per dose:
10 animals per sex and dose
Control animals:
yes, plain diet
Clinical signs:
no effects observed
Description (incidence and severity):
The clinical observations detected during this study were not considered to be related to systemic toxicity.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No adverse effect on bodyweight development or bodyweight gain was detected.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No adverse effect on bodyweight development or bodyweight gain was detected.
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Histopathogical examinations revealed the following treatment-related effect:
Other effects:
no effects observed
Description (incidence and severity):
Test substance intake: No adverse effect on bodyweight development or bodyweight gain was detected.
Reproductive function: oestrous cycle:
no effects observed
Description (incidence and severity):
No treatment-related effects were detected in the length of gestation.
Reproductive function: sperm measures:
no effects observed
Description (incidence and severity):
No treatment-related effects were detected in mating performance or fertility.
Reproductive performance:
no effects observed
Description (incidence and severity):
No treatment-related effects were detected in mating performance or fertility.
Key result
Dose descriptor:
NOEL
Effect level:
125 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: see 'Remark'
Key result
Dose descriptor:
NOAEL
Effect level:
125 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: see 'Remark'
Critical effects observed:
no
Clinical signs:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Mortality / viability:
no mortality observed
Description (incidence and severity):
No significant differences were detected in litter sizes, sex ratio and viability for treated groups when compared to controls.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Sexual maturation:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Gross pathological findings:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Histopathological findings:
no effects observed
Description (incidence and severity):
There were no significant differences in litter weights or adverse effects on mean offspring bodyweights or surface righting between control and treated animals. No obvious clinical signs of toxicity were detected.
Key result
Dose descriptor:
NOEL
Generation:
F1
Effect level:
125 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
sexual maturation
clinical signs
mortality
body weight and weight gain
organ weights and organ / body weight ratios
gross pathology
Critical effects observed:
no
Reproductive effects observed:
no
Conclusions:
No treatment-related effects were detected in the reproductive parameters measured, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 125 mg/kg/day.
Effect on fertility: 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:
Study according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods. Klimisch rating = 1
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
No treatment-related effects were detected in the reproductive parameters measured,
therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 125 mg/kg/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.7 this substance is not causing concern to be toxic to reproduction.

Additional information