Registration Dossier
Registration Dossier
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EC number: 915-680-2 | CAS number: -
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Remarks:
- Not applicable ( prior to 1981)
Test material
- Reference substance name:
- Reaction mass of phosphonic acid, methyl-, bis[(5-ethyl-2-methyl-2,2-dioxido-1,3,2-dioxaphosphorinan-5-yl)methyl] ester with (5-ethyl-2-methyl-2-oxido-1,3,2-dioxaphosphorinan-5-yl)methyl methyl methylphosphonate
- EC Number:
- 915-680-2
- Cas Number:
- 170836-68-7
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- Reaction mass of phosphonic acid, methyl-, bis[(5-ethyl-2-methyl-2,2-dioxido-1,3,2-dioxaphosphorinan-5-yl)methyl] ester with (5-ethyl-2-methyl-2-oxido-1,3,2-dioxaphosphorinan-5-yl)methyl methyl methylphosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mated female rabbits
- Sex:
- female
Administration / exposure
- Route of administration:
- not specified
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Administration of the substance to pregnant female rabbits at doses of 300, 1000 and 3000 mg/kg produced gastrointestinal effects (diarrhea) at the high level
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 other: mg/kg
- Dose / conc.:
- 1 000 other: mg/kg
- Dose / conc.:
- 3 000 other: mg/kg
- No. of animals per sex per dose:
- 15
- Control animals:
- not specified
- Details on study design:
- Administration of the substance to pregnant female rabbits at doses of 300, 1000 and 3000 mg/kg produced gastrointestinal effects (diarrhea) at the high level. Deaths which could not be attributed to other causes also occurred at the high dose level. There was a decrease in the mean body weight of females at the high dose level on Days 12, 18 and 29 of gestation.
Examinations
- Litter observations:
- observations of the uterine contents showed that the ratio of live fetuses/implantation sites is significantly decreased in the 3000 mg/kg group as compared to the controls.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There was a decrease in the mean body weight of females at the high dose level on Days 12, 18 and 29 of gestation.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The observations of the uterine contents showed that the ratio of live fetuses/implantation sites is significantly decreased in the 3000 mg/kg group as compared to the controls.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Key result
- Dose descriptor:
- other: NOAC
- Effect level:
- 3 000 mg/kg diet
- Based on:
- not specified
- Sex:
- female
- Basis for effect level:
- other: not specified
Target system / organ toxicity (P0)
- Critical effects observed:
- no
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- not determinable
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 3 000 mg/kg diet
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Evaluation of cleared specimens showed a significant increase in the number of uncommonly-encountered changes at the 300 and 1000 mg/kg dose levels. These changes were judged to reflect an inhibition in the rate of skeletal development and were not observed in the high dose tested group. The NOAC for maternal toxicity and reproduction toxicity is considered to be 3000 mg/kg.
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