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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Based on the explanation given in the read-across assessment framework document (attached in IUCLID section 13.2) an analogue approach for read-across of the endpoint “developmental toxicity" from the structural analogues to the target substance is considered justified.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Species:
rat
Key result
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
no effects where observed with neither of the two source substances (managnese alumina pink corundum and chromium iron oxide)
Abnormalities:
no effects observed
Key result
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
no effects where observed with neither of the two source substances (managnese alumina pink corundum and chromium iron oxide)
Abnormalities:
no effects observed
Developmental effects observed:
no

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion