Registration Dossier
Registration Dossier
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EC number: 223-296-5 | CAS number: 3811-73-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pyridine-2-thiol 1-oxide, sodium salt
- EC Number:
- 223-296-5
- EC Name:
- Pyridine-2-thiol 1-oxide, sodium salt
- Cas Number:
- 3811-73-2
- Molecular formula:
- C5H5NOS.Na
- IUPAC Name:
- sodium (1-oxo-1λ⁵-pyridin-2-yl)sulfanide
- Details on test material:
- - Analytical purity: 40.8%
- Lot/batch No.: 99072150
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan Srl
- Age at study initiation: 9 weeks
- Weight at study initiation: 200-287g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- Each male was used to mate up to 3 females. Separation after successful mating.
- Duration of treatment / exposure:
- Day 6 to Day 19 (including) of gestation. Presence of vaginal plug or sperm in the vaginal smear were taken as signs of "Day 0" of gestation.
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- -Body weight
-Food consumption
-Clinical signs - Ovaries and uterine content:
- -Gravid uterine weight
-Number of corpora lutea
-Number of implantations
-Evaluation of placenta - Fetal examinations:
- -Litter size
-Number of dead foetuses (divided in early and late resoprtions)
-Foetal weight
-Sex ratio
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Lower body weight development and lower food consumption in high dosed females.
Difficulty in movement, impairment of hindlimbs, hunched posture and emaciation in the high dosed group.
Significant reduction in uterus weight in high dosed animals, compared to the control.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 4 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Mean foetal weight was statistically lower in high dosed animals, compared to the control. Higher incidence of small foetuses in high dosed animals, compared to the control. This finding is related to maternal toxicity.
Higher incidence of incompletely ossifications of sternebrae, metacarpals and metatarsals in high dosed animals, compared to the control. These findings are related to maternal toxicity.
No evidence of a teratogenic effect of the test substance was obtained.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg bw/day (nominal)
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- LOAEL
- Effect level:
- 4 mg/kg bw/day (nominal)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No evidence of a teratogenic effect of the test substance was obtained. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
