Registration Dossier
Registration Dossier
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EC number: 201-368-7 | CAS number: 81-64-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Peer reviewed research document
Testing on methylhydroxyanthroquinone. Considered good surrogate for read-across
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,3,8-trihydroxy-6-methylanthraquinone
- EC Number:
- 208-258-8
- EC Name:
- 1,3,8-trihydroxy-6-methylanthraquinone
- Cas Number:
- 518-82-1
- Molecular formula:
- C15H10O5
- IUPAC Name:
- 6-methyl1,3,8-trihydroxyanthraquinone
Constituent 1
- Specific details on test material used for the study:
- Based on the herbal medicine Emodin
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- Rats also tested and details included in the report.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Mated prior to exposure perion. Mating dates recorded so dosing could start on on correct Gestation Day (GD)
- Duration of treatment / exposure:
- For mice, 11 days GD 6 -17
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 94 mg/kg bw/day (nominal)
- Dose / conc.:
- 391 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 005 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 23 to 25
- Control animals:
- yes, plain diet
Examinations
- Maternal examinations:
- Yes
- Ovaries and uterine content:
- Yes
- Fetal examinations:
- Yes
- Statistics:
- Not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight gain during treatment was significantly reduced at the high dose.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced food intact in high dose group.
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 391 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
Maternal abnormalities
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- No abnormalitied
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- effects observed, treatment-related
- Description (incidence and severity):
- Litter size unaffected, but foetal bodyweight reduced
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- not examined
- Other effects:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 144 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Other than poor weight gain, no other adverse effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Prenatal mortality, live litter size, fetal sex ratio, and morphological development were unaffected
Applicant's summary and conclusion
- Conclusions:
- Study performed on the herbal drug Emodin did not result in any developmental toxicity in Rats or mice.
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