Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Data waiving: The study does not need to be conducted because a pre-natal developmental toxicity study is available (read-across).
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Data waiving: A pre-natal developmental toxicity study is 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
Key study: Based on read-across approach from analogue substance FB220, the NOEL of the substance P-1057 is calculated to be 1498.9 mg/kg bw/day for both maternal and developmental toxicity.
Link to relevant study records
- 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 for cross-reference:
- 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:
- 1 498.9 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 for which NOEL = 1000mg/kg-bw/day
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- Developmental toxicity
- Effect level:
- 1 498.9 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 for which NOEL = 1000mg/kg-bw/day
- 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 1498.9 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-1057 was determined to be 1498.9 mg/kg bw/day.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 498.9 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Key study: Read across from a high quality study (Klimish score=1) from an analogue substance.
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
Key study. Test method according to OECD 414 in rats. GLP study. Read across from a study with an analogue substance: No toxicity was observed at any of the tested doses. Based on the read-across the NOEL was 1498.9 mg/kg-bw/day
Justification for classification or non-classification
Based on the available data, the substance is not classified for reproductive toxicity according to CLP Regulation.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
