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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 902-591-9 | CAS number: -
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- missing positive control
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Evidence that methanol inhalation does not induce chromosome damage in mice.
- Author:
- Campell, J.A., Howard, D.R., Backer, L.C., Allen, J.W.
- Year:
- 1 991
- Bibliographic source:
- Mutation Research 260 (3), 257-264
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- - primary lung cells in addition to erythrocytes, not included in the guideline; no positive control (only historical)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- Methyl alcohol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: C57BL/6J
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 10 weeks old
- Housing: Mice were housed in an animal facility in laminar-flow rooms
- Diet (e.g. ad libitum): Purina rodent chow
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Air changes (per hr): 15 cycles/hour of biocleaned air
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- none
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure: Methanol was vaporised and transported by nitrogen and HEPA-filtered air to stainless steel chambers.
- Air flow rate: 105 L/min
- Air change rate: 15 air changes/hours
TEST ATMOSPHERE
- Brief description of analytical method used:
Chamber methanol concentrations, monitored continuously by a Foxboro Miran 1A Infrared Analyser, indicated that ppm levels did not differ by more than 7% from calculated values. - Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- 6 h/day
- Post exposure period:
- no
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5.3 mg/L air
- Dose / conc.:
- 1.04 mg/L air
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- No positive control group was concomitantly examined. Historical positive controls are available.
Examinations
- Tissues and cell types examined:
- peripheral blood; primary cultures of lung cells
- Details of tissue and slide preparation:
- Peripheral blood cell MN analysis:
Immediately following the last exposure, animals were anesthetised and blood smears were made from tail vein blood for erythrocyte MN determination. The cells were fixed in methanol and stained with acridine orange for fluorescence microscopy. All slides were coded prior to scoring of 2000 polychromatic erythrocytes (PCE) and 2000 normochromatic erythrocytes (NCE) per animal.
Lung cell MN analysis:
The same exposure groups of mice used for blood MN analysis were also used for lung cell MN analysis. After blood was removed by perfusion, the lungs were infused with a trypsin, EDTA and collagenase solution; and then removed, minced and incubated in the same enzyme solution. The cells were collected and culture dishes with 160,000 viable cells per animal were established. Lung MN were analysed in 1000 binucleated cells typically examined from each of 5 animals per dose. Percentages of mononucleated, binucleated, trinucleated and quadrinucleatexd cells were also determined. - Statistics:
- A 1- way analysis of variance was performed with Statgraphics statistical package. MN data were then analysed by a 1-tailed Dunnett´s test.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not examined
- Positive controls validity:
- other: historical positive controls
- Additional information on results:
- No treatment related effect on micronuclei frequency or cell kinetics and no toxicity were seen at any dose level:
Peripheral blood cell MN analysis:
Mean MN rates were 3.1/1000 and 5.2/1000 in PCE, and 3.4/1000 and 3.6/1000 in NCE at either dose, respectively, vs. 5.0/1000 and 3.7/1000 of respective controls.
Lung cell MN analysis:
Mean MN rates were about 20/1000 to 24/1000 irrespective of a dose or control group. The ratio of bi- to mononucleated cells was not influenced by the treatment, neither was there evidence of a treatment-related increase in the incidence of multi-nucleated cells.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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.