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Toxicological information

Developmental toxicity / teratogenicity

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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:
2004

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

Constituent 1
Chemical structure
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
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.