Registration Dossier
Registration Dossier
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EC number: 226-408-0 | CAS number: 5395-50-6
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Human Health Tier II Assessment For N-Methylol imidazolidones
- Author:
- Accelerated Assessment of Industrial Chemicals in Australia (IMAP)
- Bibliographic source:
- https://www.nicnas.gov.au/chemical-information/imap-assessments
Materials and methods
Test material
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- organ weights and organ / body weight ratios
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: no effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: no effects observed
Target system / organ toxicity (F2)
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a 2-generation oral reproductive toxicity study in rats, the NOAEL for maternal toxicity was determined as 100 mg/kg bw/day due to increased liver weights in the higher dose groups (up to 1000 mg/kg bw/day). The NOAEL for reproduction was 1000 mg/kg bw/day for both generations. The development of pups was not affected by treatment up to 1000 mg/kg bw/day. No further study details were reported
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