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EC number: 215-892-9 | CAS number: 1445-45-0
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- limited documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicological Research of Methanol as a fuel for Power Station. Summary Report on Tests with Monkeys, Rats and Mice.
- Author:
- New Energy Development Organization
- Year:
- 1 987
- Bibliographic source:
- New Energy Development Organization, Tokyo
- Reference Type:
- publication
- Title:
- Long-term effects of methanol vapor at low concentration.
- Author:
- Takeda, K. and Katoh, N.
- Year:
- 1 988
- Bibliographic source:
- Proc. of the 8th Int. Symp. Alcohol Fuels, 1051-1056, Tokyo, Japan
- Reference Type:
- publication
- Title:
- Methanol, Environmental Health Criteria 196
- Author:
- IPCS/WHO
- Year:
- 1 997
- Bibliographic source:
- International Programme on Chemical Safety, World Health Organisation Geneva, 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- - limited documentation
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- methanol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Inc.
- Age at study initiation: 6 weeks
- Housing: The animals were housed individually in wire-mash cages attached to the inhalation chamber.
- Diet (e.g. ad libitum): solid chow for mice (CRF-1, Charles River Japan Inc.)
- Water (e.g. ad libitum): filtered and sterilised tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 15 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: not applicable
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Hazleton 1000 Inhalation Exposure Chamber - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical control of chamber concentration: analytical values close to nominal ones.
- Duration of treatment / exposure:
- 12 months (males: 7202-7225 h; females: 7352-7373 h)
- Frequency of treatment:
- continuously, mean daily exposure time: 19.8 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.013 mg/L air (nominal)
- Remarks:
- corresponding to 10 ppm
- Dose / conc.:
- 0.13 mg/L air (nominal)
- Remarks:
- corresponding to 100 ppm
- Dose / conc.:
- 1.3 mg/L air (nominal)
- Remarks:
- corresponding to 1000 ppm
- No. of animals per sex per dose:
- 30
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Measurements were carried out on all animals once a week.
FOOD CONSUMPTION:
- The measurements were done weekly during the first 13 weeks of exposure, and monthly thereafter.
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
For interim examination, 10 animals per sex and dose were sacrificed after 6 months. - Statistics:
- All the data obtained were analysed by t-test, Fischer´s exact test or Armitage´s chi-square test as appropriate for any significant difference.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- During the whole study, there were no changes in the general appearance that could suggest any relation to methanol treatment.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One female animal of the 0.13 mg/L group died on day 174, another female animal (also of the 0.13 mg/L group) had to be sacrificed in moribund state on day 178.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The body-weights of both sexes of the treated groups tended to be higher than the controls in the second half of the study (NEDO, Fig. 3, p. 168).
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- There was decreased food consumption in high-dose females during the first 2 months and from month 7 throughout the study.
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- All clinical and blood tests failed to reveal any methanol-related alteration in parameters from normal.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- All clinical and blood tests failed to reveal any methanol-related alteration in parameters from normal.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- Urinary protein was in the normal range of physiological variations. None of pH, glucose, ketones, bilirubin, occult blood or urobilinogen showed any changes suggesting effects from the treatment.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- In the group of high-dose females, an increase in organ weight with significant differences was noted for the liver after 6 months and for the kidney and spleen after 12 months, however, the latter without statistical significance and a clear dose-response.
The organ/body weight ratio did not show any significant difference. - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathological examinations revealed various non-tumoral changes. Except for vacuolar degeneration of the ureter epithelium at the kidney, all findings were observed due to aging or of accidental nature commonly seen in mice of this age and strain (6 or 12 month old, B6C3F1).
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Necropsy of animals sacrificed after 6 or 12 months of treatment revealed a sporadical incidence of accidental changes for both males and females. But there were no changes which occurred in a high incidence or specifically in the treated groups.
The two females of the mid-dose group (0.13 mg/L) which died or were sacrificed in extremis had thoracic or abdominal dropsy, atrophy of the thymus and spleen, severe roughness and grey-coloration of the kidney surface.
Liver: After 12 months, the incidence of more severe fatty degeneration of hepatocytes was pronounced in high-dose males: This was graded as moderate in 8/20, mild in 8/20 and negative in 4/20 surviving males vs. 1/20 (moderate), 9/20 (mild) and 10/20 negative in the male control group. On the other hand, this effect was common and found to similar extent in untreated/external male mice. The female mice showed no difference among the groups compared to control.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1.3 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: histopathological examinations; body weight; food consumption; organ weights
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- 0.13 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: histopathological examinations; body weight; food consumption; organ weights
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
According to the authors, only in the 1.3 mg/L dose-group changes could be considered treatment-related. But based on the minor degree and severity, these changes have no pathological meaning and are considered as toxicologically irrelevant.
Levels of 0.13 mg/L or less did not produce any effect (=NOEC). 1.3 mg/L can be established as NOAEC, while it is the LOEC for non-pathological, apparently treatment-related 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.
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