Registration Dossier
Registration Dossier
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EC number: 233-032-0 | CAS number: 10024-97-2
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of low intermittent concentrations of nitrous
oxide on the developing rat fetus - Author:
- Vieira E, Cleaton-Jones P, Moyes D
- Year:
- 1 983
- Bibliographic source:
- Br J Anaesth 55: 67–69 cited in 'Nitrous oxide [MAK Value Documentation, 2007]'
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 12 Wistar rats per group were exposed 6 h/day, 5d/week during GD 1- 19 to nitrous oxide. Fetuses were examined on GD 19.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Dinitrogen oxide
- EC Number:
- 233-032-0
- EC Name:
- Dinitrogen oxide
- Cas Number:
- 10024-97-2
- Molecular formula:
- N2O
- IUPAC Name:
- nitrogen oxide
- Test material form:
- gas
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- air
- Duration of treatment / exposure:
- Exposure from GD1 to GD19
- Frequency of treatment:
- 6 h/d, 5d / week
- Duration of test:
- 19 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 ppm
- Remarks:
- (0.025%)
- Dose / conc.:
- 500 ppm
- Remarks:
- (0.05%)
- Dose / conc.:
- 1 000 ppm
- Remarks:
- (0.1%)
- Dose / conc.:
- 5 000 ppm
- Remarks:
- (0.5%)
- No. of animals per sex per dose:
- 12 gravid females per dose group
- Control animals:
- yes
Examinations
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- No resorptions observed.
Effect levels (maternal animals)
- Key result
- Remarks on result:
- not measured/tested
Maternal abnormalities
- Key result
- Abnormalities:
- not examined
Results (fetuses)
- Changes in litter size and weights:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced litter size at 5000 ppm.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1 000 ppm
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- changes in litter size and weights
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 5 000 ppm
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
Applicant's summary and conclusion
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.
