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Diss Factsheets
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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
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
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- 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
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 78 wks
- Frequency of treatment:
- mice were exposed 4h/d, 5d/wk
- Post exposure period:
- 78 wks
- Remarks:
- Doses / Concentrations:
0, 10, 40%
Basis:
nominal conc. - No. of animals per sex per dose:
- 75-77 animals/sex/treatment gp
88-91 animals/sex/treatment gp - Control animals:
- yes, concurrent no treatment
- Dose descriptor:
- NOAEC
- Effect level:
- > 400 000 ppm
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Reference
More than 40 tissues were examined and fixed. Liver, spleen, kidneys and testes were weighed. Haematology was limited to bone marrow and blood smears (the latter for RBC, differential white blood cell, reticulocyte and platelets counts).
No treatment related significant decrease in body weights. Gross and microscopic examination of tissues revealed a variety of non-neoplastic lesions including ovarian cyst, cholecystitis, bladder stones and testicular atrophy. Their presence was unrelated to treatment. In general, there was no microscopic evidence of cellular damage and in particular a detailed examination of blood smears and bone marrow sections showed no evidence of megaloblastic changes or bone marrow depression.
The first neoplastic lesion appeared 26 weeks after the start of treatment and numerous other tumours appeared throughout the study. Most of the tumours in both the control and test animals were either lung adenomas or alveolar cell origin or liver tumours of the basophilic hepatocellular adenoma type. There were no statistical differences among the groups either in the total number of tumours or in the number of tumours of a particular cell type.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 400 000 mg/m³
- Study duration:
- chronic
- Species:
- mouse
Justification for classification or non-classification
In accordance with the REACh endpoint specific guidance: -
“For substances which there is no concern for mutagenic activity, and no other toxicological indicators of carcinogenicity (i.e. for the substance itself or for structurally-related substances), there is no need for further consideration of its carcinogenic potential.”N2O is confirmed to be devoid of mutagenic potential, with the repeat dose toxicity studies showing no evidence of pre-cancerous lesions. Furthermore, human epidemiological data confirms no convincing evidence that N2O poses a carcinogenic hazard to humans. Therefore no classification is required.
Additional information
The incidence of tumours in male and female Swiss Webster mice treated with N2O at concentrations of 0, 10% (100000mg/m3) or 40% (400000 mg/m3), 4h/d, 5d/wk for 78 wks was not increased. In the high dose group body weights were reduced by 5%. Other studies examining the carcinogenic effect of N2O also produced negative results, however the exposure period was either too short (Eger et al., 1978) or the concentration used was too low with N2O co-administered with halothane (Coate et al., 1979). These studies therefore have not been included in the evaluation of carcinogenicity.
References:
- Coate, W.B., Ulland, B.M. & Lewis , T.R. (1979). Chronic exposure to low concentrations of halothane-nitrous oxide: lack of carcinogenic effect in the rat. Anesthesiology, 50; pp 310-318.
- Eger II, E.I., White, A.E., Brown, C.L., Biava, C.G., Corbett, T.H. & Stevens, W.C. (1978). A test of the carcinogenicity of enflurane, isoflurane, halothane, methoxyflurane and nitrous oxide in mice. Anesth Analg, 57; pp 678-694
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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