Registration Dossier
Registration Dossier
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EC number: 233-032-0 | CAS number: 10024-97-2
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 subchronic intermittent exposure to nitrous oxide in Swiss Webster mice
- Author:
- Rice SA, Mazze RI, Baden JM
- Year:
- 1 985
- Bibliographic source:
- J environm Path Toxicol 6: 271–281 cited in 'Nitrous oxide [MAK Value Documentation, 1993]'
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (90-Day (Subchronic) Inhalation Toxicity Study
- Deviations:
- yes
- Remarks:
- Limited haematology and pathology
- 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:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Duration of treatment / exposure:
- 14 weeks
- Frequency of treatment:
- 4 h/d, 5 d/w
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 000 ppm
- Remarks:
- (0.5%)
- Dose / conc.:
- 50 000 ppm
- Remarks:
- (5%)
- Dose / conc.:
- 500 000 ppm
- Remarks:
- (50%)
- No. of animals per sex per dose:
- 27
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Liver microsomal cytochrome P-450 content and the rates of defluorination of enflurane and methoxyflurane were determined.
Results and discussion
Results of examinations
- Mortality:
- no mortality observed
- Description (incidence):
- All animals survived to the scheduled necropsy.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment related decreases in body weight were observed at 500 000 ppm with a depression of 77 and 63% in body weight gain in males and females respectively. This depression in weight gain was statistically significant (p<0.025 and p<0.01, respectively).
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were observed in any of the parameter measured.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were observed in any of the parameter measured.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were observed in any of the parameter measured. No impairment of the testis weight was observed.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No histological changes in the liver, kidneys or adrenal gland were detected.
- Other effects:
- no effects observed
- Description (incidence and severity):
- Neither the hepatic microsomal cytochrome P-450 content nor the rates of anesthetic defluorination were increased. No enzyme induction or inhibition could be observed.
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 50 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: corresponds to 90909 mg/m3
Target system / organ toxicity
- Critical effects observed:
- no
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.
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