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Diss Factsheets
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EC number: 237-424-2 | CAS number: 13780-06-8
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- OECD SIDS (2005) describe as "critical study for SIDS endpoint", but with a reliability score of 4 ("not assignable") as it could not be evaluated by OECD assessors. Study evidently to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- review article or handbook
- Title:
- SIDS Initial Assessment Report (SIAR) for SIAM 20. Sodium nitrite, CAS No: 7632-00-0.
- Author:
- OECD
- Year:
- 2 005
- Bibliographic source:
- Organization for Economic Co-operation and Development. Screening Information Dataset.
- Report date:
- 2005
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
- Principles of method if other than guideline:
- It is not apparent from the citing OECD SIDS (2005) review if an official test guideline was followed.
Groups of Wistar rats (10/sex) were exposed (nose-only) for 4 hours to sodium nitrite aerosols, generated from solutions in deionised water, at target concentrations of 10 or 100 mg/m3. Aerosols dried rapidly so animals were exposed to dry particulate test material. Mass mean aerodynamic diameter was 1.7 and 2.0 μm for the low and high groups respectively. Methaemoglobin levels were measured after exposure and the remaining animals maintained for 14 days, and then subject to a full post-mortem examination. - GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium nitrite
- EC Number:
- 231-555-9
- EC Name:
- Sodium nitrite
- Cas Number:
- 7632-00-0
- Molecular formula:
- HNO2.Na
- IUPAC Name:
- sodium nitrite
- Test material form:
- aerosol dispenser: not specified
- Details on test material:
- [No further details provided in citing OECD and ECB reviews]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified in citing OECD and ECB reviews
- Females (if applicable) nulliparous and non-pregnant: not specified in citing OECD and ECB reviews
- Age at study initiation: not specified in citing OECD and ECB reviews
- Weight at study initiation: not specified in citing OECD and ECB reviews
- Fasting period before study: not specified in citing OECD and ECB reviews
- Housing: not specified in citing OECD and ECB reviews
- Diet (e.g. ad libitum): not specified in citing OECD and ECB reviews
- Water (e.g. ad libitum): not specified in citing OECD and ECB reviews
- Acclimation period: not specified in citing OECD and ECB reviews
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified in citing OECD and ECB reviews
- Humidity (%): approximately 60%
- Air changes (per hr): not specified in citing OECD and ECB reviews
- Photoperiod (hrs dark / hrs light): not specified in citing OECD and ECB reviews
IN-LIFE DATES: not specified in citing OECD and ECB reviews
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- not specified
- Mass median aerodynamic diameter (MMAD):
- ca. 1.7 - ca. 2 µm
- Remark on MMAD/GSD:
- Mass mean aerodynamic diameter was 1.7 and 2.0 μm for the low and high groups respectively. GSD was not specified in citing OECD and ECB reviews.
- Details on inhalation exposure:
- [No further details provided in citing OECD and ECB reviews]
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- High dose achieved 95.1 mg/m3
- Duration of exposure:
- 4 h
- Concentrations:
- 10 or 100 mg/m3 [high dose evidently achieved 95.1 mg/m3]
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified in citing OECD and ECB reviews
- Necropsy of survivors performed: yes
- Other examinations performed: methaemoglobin levels following exposure - Statistics:
- [Not specified in citing OECD and ECB reviews]
Results and discussion
- Preliminary study:
- [Not specified in citing OECD and ECB reviews]
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 100 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortaility observed up to 14 days post exposure.
- Clinical signs:
- other: None specified [extent of assessment unclear from citing OECD and ECB reviews]
- Body weight:
- [Unclear if body weights assessed from citing OECD and ECB reviews]
- Gross pathology:
- None reported
- Other findings:
- "Methaemoglobin was significantly increased above concurrent control values only in females exposed to 10 mg/m3. However, the increase was judged to be not haematologically
significant as the value was within the range seen for control animals of this age. Further there was no significant increase in males. There were no toxicologically significant effects on animals maintained for 14 days post-exposure".
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- According to OECD (2005) and ECB (2000), briefly describing the findings of an unpublished GLP acute inhalation study, there was no mortality or other toxicologically significant adverse effects in rats (10/sex/group) during a14-day observation period following a 4-hr exposure to up to 100 mg/m3 of sodium nitrite. As such, a 4-hr LC50 of >100 mg/m3 can be concluded for sodium nitrite.
- Executive summary:
According to OECD (2005) and ECB (2000), briefly describing the findings of an unpublished GLP acute inhalationstudy, groups of 10 male and 10 female Wistar rats were exposed nose only for 4 hours to sodium nitrite aerosols, generated from solutions in deionised water, at target concentrations of 0, 10 or 100 mg/m3 (and achieving 95.1 mg/m3). Aerosols dried rapidly so animals were exposed to dry particulate test material. Mass mean aerodynamic diameter was 1.7 and 2.0 μm for the low and high groups respectively. Methaemoglobin levels were measured following exposure. The remaining animals were maintained for 14 days, and then subject to a “full post-mortem examination”.
No mortality or other toxicologically significant adverse effects were reported. As such, a 4-hr LC50 of >100 mg/m3 can be concluded for sodium nitrite.
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