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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 421. See chapter 13 report for a more detailed justification.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 421.
See chapter 13 report for a more detailed justification.
Reason / purpose for cross-reference:
read-across source
Clinical signs:
effects observed, treatment-related
Reproductive function: oestrous cycle:
no effects observed
Dose descriptor:
NOAEL
Effect level:
225 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
Critical effects observed:
no
Clinical signs:
no effects observed
Dose descriptor:
NOEL
Generation:
F1
Effect level:
225 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
Critical effects observed:
no
Reproductive effects observed:
no
Conclusions:
For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 421.
See chapter 13 report for a more detailed justification.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
225 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification and labelling is warranted for the reproduction parameters.

Additional information