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EC number: 204-468-9 | CAS number: 121-43-7
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures in accordance with accepted standard methods, 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:
- 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
- Details on test material:
- - Name of test material (as cited in study report): methanol (reagent special grade from Junsei Chemicals Co.)
- Physical state: vapour
- Analytical purity: no data
- Impurities (identity and concentrations): < 1 ppm vinyl chloride, < 3 ppm formaldehyde
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Inc.
- Housing: The animals were housed individually in wire-mash cages attached to the inhalation chamber.
- Diet (e.g. ad libitum): solid chow for rats (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: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: no data
- 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 (total exposure time: 7318-7341 h: males; 7474 - 7496 h: females)
- Frequency of treatment:
- continuously, average about 20 h/d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.013; 0.13; 1.3 mg/L (corresponding to 10; 100; 1000 ppm)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION:
- The feed to be consumed during a week was determined for two animals, and the daily food consumption per animal was then calculated. The calculation was 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 - 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
- Details on results:
- CLINICAL SIGNS AND MORTALITY
One female rat of the 1.3 mg/L dose group and one male rat of the 0.013 mg/L dose group died or were sacrificed in extremis (on day 337 and on day 340, respectively). This was considered spontaneous on the basis of the absence of a consistent dose relationship.
BODY WEIGHT GAIN AND FOOD CONSUMPTION
A very slight transient suppression of body-weight gain was observed for males and females of the 1.3 mg/L dose group from week 27 through 44 (less than 5 %). This has to be attributed to temporary occurrence of slight diarrhea in these groups during this period. The otherwise addressed significant decreases in body weight at the end of the study are not noticable in Fig. 3 representing the time-course of body weight development. The high-dose males showed a minimal, but significant decrease in food consumption from week 30 to the end. However, this was not more than about 5- % of the control.
HAEMATOLOGY
Hematologic examinations revealed no clear changes which could be attributed to exposure to methanol.
CLINICAL CHEMISTRY
Serum biochemical examination showed a small tendency to decrease for alkaline phosphatase, the enzymatic activities of GOT, GPT, LDH and gamma-GTP did not show any differences.
Free fatty acid showed lower values in all exposure groups without dose-response relationship. Cholesterol and triglyceride remained unchanged.
Changes of other clinical-chemical parameters showed no correlation with the methanol exposure.
URINALYSIS
Urinalysis showed no changes suggesting effects from exposure to methanol.
ORGAN WEIGHTS
Data of the organ/body weight ratio revealed a dose-related upward tendency in the liver and spleen for females which remained within a 5-% range.
GROSS PATHOLOGY
no data
HISTOPATHOLOGY:
Histopathological examinations showed a variety of non-tumoral changes in various organs, many of them were infrequent findings which were possibly accidental. For tumoral changes, similarly, almost all the findings observed were considered spontaneous ones due to aging.
Except for swelling of chromophobic cells of the pituitary, there was no findings which could be related to exposure level.
Effect levels
open allclose all
- Dose descriptor:
- NOEC
- Effect level:
- 0.13 mg/L air (nominal)
- Sex:
- male/female
- Dose descriptor:
- LOAEC
- Effect level:
- 1.3 mg/L air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: body weight and food consumption; organ/body weight ratio; swelling of the chromophobic cells of the pituitary
Target system / organ toxicity
- Critical effects observed:
- not specified
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 may be considered as toxicologically irrelevant.
Levels of 0.13 mg/L or less (at 20 h/d) did not produce any effect (= NOEC). 1.3 mg/L is adopted as LOAEC, although it may
be considered as a NOAEC.
Applicant's summary and conclusion
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