Registration Dossier
Registration Dossier
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EC number: 430-650-4 | CAS number: 151841-65-5
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3 000 - < 10 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- body weight and weight gain
- food consumption and compound intake
- food efficiency
- clinical biochemistry
- reproductive function (oestrous cycle)
- reproductive performance
- other:
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 10 000 mg/kg diet
- System:
- other:
- Organ:
- mesenteric lymph node
- preputial gland
- other:
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
Target system / organ toxicity (P1)
- Key result
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 3 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Results: F2 generation
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- >= 3 000 mg/kg diet
- Based on:
- other:
- Sex:
- male/female
- Basis for effect level:
- other:
Target system / organ toxicity (F2)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 10 000 mg/kg diet
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
- Relevant for humans:
- no
Applicant's summary and conclusion
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.
