Registration Dossier

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:
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
Study period:
1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
Reason / purpose:
read-across source
Principles of method if other than guideline:
Read-across approach from data on an analogue substance.
Limit test:
no
Key result
Dose descriptor:
NOEL
Remarks:
Maternal toxicity
Effect level:
1 000 mg/kg bw (total dose)
Based on:
test mat.
Basis for effect level:
other: No adverse effects observed at any dose tested.
Remarks on result:
other: Based on a read across from an analogue substance.
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOEL
Remarks:
Developmental toxicity
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects observed at any dose tested.
Remarks on result:
other: Based on a read-across from an analogue substance.
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Conclusions:
Based on the read-across approach, the NOEL for pre-natal developmental toxity by oral route in rats was determined to be 1000 mg/kg bw/day.
Executive summary:

Based on experimental results obtained in a study according to OECD 414 on the analogue substance FB220 where the test item did not produce developmental and/or maternal toxicity, the read-across approach is applied and the NOEL for pre-natal developmental toxity by oral route in rats for the subtance P-1401 was determined to be 1000 mg/kg bw/day.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion