Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 233-032-0 | CAS number: 10024-97-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
In the available carcinogenicity study on mice exposed to nitrous oxide no increase of tumour incidences was observed.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- experimental study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 303 male and female Swiss Webster mice were treated with nitrous oxide concentrations of 100000 or 400000 ml/m3, 4 hours per day, 5 days per
week. After 78 weeks of exposure, there was a 5-week period without treatment following which surviving mice were killed and examined for non-neoplastic and neoplastic lesions. - GLP compliance:
- no
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Route of administration:
- inhalation: gas
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Duration of treatment / exposure:
- 4 h/d, 5d/w
- Frequency of treatment:
- 78 weeks
- Post exposure period:
- 5 weeks
- Dose / conc.:
- 100 000 ppm
- Remarks:
- (10%)
- Dose / conc.:
- 400 000 ppm
- Remarks:
- (40%)
- No. of animals per sex per dose:
- 10% N2O: 75M; 77F
40% N2O: 76M; 75F
Control: 91M; 88F - Control animals:
- yes, concurrent no treatment
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
HAEMATOLOGY: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- In the 10% N2O group 18/75 male and 14/77 female animals died, and in the 40% N2O group 36/76 males and 18/75 females died. However, in the control goup 23/91 males and20/88 females died during the course of the study.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean body weights for male and female mice in the 10% N2O group were the same as those in the air control group throughout the study, whereas they were 5% less in the 40% N2O group.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No morphological or functional effects on the mouse hematopoietic system were observed.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Mean organ weights for N2O-treated mice were not statistically different from those of control mice.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Gross examination of tissues revealed a variety of lesions; however, their presence was unrelated to treatment.
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Microscopic examination of tissues revealed a variety of non-neoplastic lesions; however, their presence was unrelated to treatment.
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Microscopic examination of tissues revealed a variety of neoplastic lesions; however, their presence was unrelated to treatment.
- Dose descriptor:
- NOAEC
- Effect level:
- 100 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 400 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: neoplastic
- Key result
- Critical effects observed:
- no
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 727 273 mg/m³
- Study duration:
- chronic
- Species:
- mouse
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The criteria for classification for carcinogenicity according to Regulation (EC) No 1272/2008, as amended for fifteenth time in Regulation (EU) No 2020/1182, are not met.
Additional information
Carcinogenicity: via inhalation route
A carcinogen bioassay of nitrous oxide was performed in groups of male and female Swiss-Webster mice exposed to either air (n = 179), 10% N2O (n = 152), or 40% N2O (n = 151) for 4 h per day, 5 days per week. After 78 weeks of exposure, there was a 5-week period without treatment following which surviving mice were killed. Mice killed at this time or dying in extremis at other times were subjected to complete autopsy unless advanced autolysis or cannibalism precluded examination. Mean body weights for male and female mice in the 10% group were the same as those in the air control group throughout the study, whereas they were 5% less in the 40% group. No morphological or functional effects on the mouse hematopoietic system were observed. Mean organ weights for treated mice were not statistically different from those of control mice. Gross and microscopic examination of tissues revealed a variety of neoplastic and non-neoplastic lesions; however, their presence was unrelated to treatment (Baden et al. 1986).
Other studies of the carcinogenic effect of nitrous oxide also produced negative results. However, either the exposure period was too short (Eger et al. 1978) or the concentration used was too low (Coate et al. 1979b) so that these studies cannot be included in the evaluation of carcinogenicity. Some epidemiological studies have demonstrated an increased tumour incidence (above all of leukaemia and lymphomas) in persons occupationally exposed to anaesthetics (mainly nitrous oxide). However, tumour types and locations were inconsistent among the epidemiological studies which are therefore not considered in the assessment of carcinogenicity of nitrous oxide (MAK value documentation (1993).
General remark
1 mL/m3 (ppm) = 1.83 mg/m3
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.