Registration Dossier
Registration Dossier
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EC number: 203-611-2 | CAS number: 108-73-6
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Guideline:
- other: unknown
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phloroglucinol
- EC Number:
- 203-611-2
- EC Name:
- Phloroglucinol
- Cas Number:
- 108-73-6
- Molecular formula:
- C6H6O3
- IUPAC Name:
- benzene-1,3,5-triol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of test:
- between day 7 and 15 of pregnancy
Doses / concentrations
- Remarks:
- 0, 200, 300 and 400 mg/kg bw/day
- No. of animals per sex per dose:
- 20 pregnant female rats per dose
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no effects observed at the highest dose level of 400 mg/kg bw/day
- Remarks on result:
- other: see attached study results
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed at the highest dose level of 400 mg/kg bw/day
- Remarks on result:
- other: see attached study results
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 400 mg/kg bw/day (nominal)
- Treatment related:
- yes
Applicant's summary and conclusion
- Conclusions:
- The substance is not teratogenic upto the highest dose level investigated (400 mg/kg bw/day)
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