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EC number: 203-509-8 | CAS number: 107-66-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented (Original in Japanese)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- publication
- Title:
- Teratogenic studies of two kinds of di-n-butyl substituted compounds in rats
- Author:
- Noda T
- Year:
- 1 996
- Bibliographic source:
- Japn J Pharmcol 71, Suppl 1, 298 (1996)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Pregnant rats were treated orally with dibutyl hydrogen phosphate (250, 500, 1000 mg/kg bw/day) on days 7-17 of gestation. Cesarean sections were performed on day 20 of gestation. The fetuses were examined for external, visceral or skeletal abnormalities.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dibutyl hydrogen phosphate
- EC Number:
- 203-509-8
- EC Name:
- Dibutyl hydrogen phosphate
- Cas Number:
- 107-66-4
- Molecular formula:
- C8H19O4P
- IUPAC Name:
- dibutyl hydrogen phosphate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- 2 mL/kg bw
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- day 7-17 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- day 20 of gestation (cesarean section)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 14 dams (vehicle)
11 dams test item/dose - Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- body weight and food consumption
organ weights: liver, kidneys, spleen thymus, gravid uterus admusted body weight gain
no. of pregnant females
no. of dams with living fetuses
no. of dams with total resorption
no. of dead dams - Ovaries and uterine content:
- no. of corpora lutea
no. of implants
Indicence of dead or resorbed fetuses - Fetal examinations:
- no. of living fetuses
sex ratio
body weight of living fetuses
external, skeletal, visceral observations - Statistics:
- yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- the adjusted body weight gain (without gravid uterus weight) was reduced in the high dose group by 22% (see Table 1 attached); not statistically significant
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- no significant changes in weights of organs: liver, kidneys, spleen, thymus gravid uterus
Maternal developmental toxicity
- Details on maternal toxic effects:
- no treatment related effects on no. of corpora lutea, incidence of dead or resorbed fetuses (early and late stage), no. of living fetuses and sex ratio (see Table 2 attached)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: not statistically significant lower adjusted body weight gain at 1000 mg/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- see Table 2 attached
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- see Table 2 attached
- External malformations:
- no effects observed
- Description (incidence and severity):
- see Table 3 attached
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- see Table 3 attached
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- see Table 3 attached
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: develpmental toxicity
- Remarks on result:
- other: The fetuses from dams receiving dibutyl hydrogen phosphate showed no evidence of external, visceral or skeletal abnormalities.
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
The fetuses from dams receiving dibutyl hydrogen phosphate showed no evidence of external, visceral or skeletal abnormalities. Dibutyl hydrogen phosphate caused no maternal of fetal toxicities in any dibutyl hydrogen phosphate treated group.
Applicant's summary and conclusion
- Conclusions:
- The fetuses from dams receiving dibutyl hydrogen phosphate showed no evidence of external, visceral or skeletal abnormalities. Dibutyl hydrogen phosphate caused no maternal of fetal toxicities in any dibutyl hydrogen phosphate treated group.
- Executive summary:
Pregnant rats were treated orally with dibutyl hydrogen phosphate (250, 500, 1000 mg/kg bw/day) on days 7-17 of gestation. Cesarean sections were performed on day 20 of gestation. The fetuses were examined for external, visceral or skeletal abnormalities.
Dibutyl hydrogen phosphate caused no maternal toxicity, besides a reduced body weight gain in the highest dose group (not statistically significant). No effects on pregnancy parameters were affected. The fetuses showed no evidence of treatment related toxicity with regard to body weight, sex ration, external, visceral or skeletal abnormalities in any dibutyl hydrogen phosphate treated group. Under the conditions of this study, the no-observed-adverse-effect levels (NOAEL) for maternal and fetal toxicities were considered to be more than 1000 mg/kg bw/day.
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