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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- documentation limited
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
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Not all parameters mentioned in the guideline were investigated, limited documentation
- Principles of method if other than guideline:
- According to national standards. Comprehensive study programme on three species (rat, mouse, monkey) including metabolic, pharmacokinetic, short-, long-term, reproduction and carcinogenicity studies.
- 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:
- Methyl alcohol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: individually
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: H 1000 multi-tiered inhalation chambers, Hazleton Systems Inc., USA (volume 2.5 m³)
- Method of holding animals in test chamber: pregnant females were individually housed in wire mash stainless steel cages with 24 rooms placed in the inhalation chamber (whole body exposure)
- Source and rate of air: filtered external air, ventilation rate of 30 (not further specified)
- Method of conditioning air: passed through a medium performance filter, a high performance filter and an activated carbon filter
- System of generating vapours: total vaporizer supplied with liquid methanol by a microprecision pump, vaporization into the filtered air
- Temperature, humidity, pressure in air chamber: 23-26°C, 50-65%, atmospheric pressure
- Air flow rate: 1250 L/min
- Air change rate: 30/h
- Method of particle size determination: not applicable
- Treatment of exhaust air: not specified
TEST ATMOSPHERE
- Brief description of analytical method used: air from the inhalation chamber was extracted at a rate of 1.0 L/min by a sampling apparatus and the methanol concentration measured by a methanol vapor analyzer incorporating an infra-red spectrophotometer. The concentration signal was transmitted to the microprecision pump and used to regulate the methanol concentration in the chamber by adjusting liquid flow.
- Samples taken from breathing zone: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical concentration values of methanol were close to nominal ones.
- Details on mating procedure:
- - Impregnation procedure: pregnant females, not further specified
- Duration of treatment / exposure:
- GD 7-17
- Frequency of treatment:
- continuously, approx. 22.7 h/d
- Duration of test:
- various durations: until Cesarian section, the age of 8 weeks, and reproduction of F1, respectively
Doses / concentrationsopen allclose all
- Dose / conc.:
- 270 mg/m³ air
- Dose / conc.:
- 1 330 mg/m³ air
- Dose / conc.:
- 6 650 mg/m³ air
- No. of animals per sex per dose:
- 36 dams per test and control group, including 12 dams allowed for natural delivery.
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
WATER CONSUMPTION: Yes
POST-MORTEM EXAMINATIONS: Yes - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Other: embryolethality - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- One dam died, another one had to be killed before delivery.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- a decrease in body-weight gain at 5000 ppm
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption was reduced during gd 7 through 12 at 5000ppm
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Drinking water consumption was reduced during gd 7 through 12 at 5000ppm
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- effects observed, treatment-related
- Description (incidence and severity):
- late resorptions: 10.4 % vs. 0.6 % in control, p<0.05 at 5000 ppm, ), but the variance between single litters was high
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- effects observed, treatment-related
- Description (incidence and severity):
- After 5000 ppm, mean gestation time was prolonged by 0.7 days.
- Changes in number of pregnant:
- not examined
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1.33 mg/L air
- Basis for effect level:
- maternal abnormalities
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 6.65 mg/L air
- Basis for effect level:
- maternal abnormalities
- mortality
- other: body weight gain, food and drinking water consumption
Maternal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean body weight of live fetuses after Cesarian section was reduced (about -20 %, p<0.001) at 5000 ppm
- Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- Among descendants from the high-dose group, mortality was prominent during the first 4 d after birth with live fetuses showing poor vitality in this time (ca. 10% = 2/12 pups per litter died as compared with 1 to 2% fatal cases in the other groups).
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Only after intra-uterine exposure to 5000 ppm: "atresia of cervical arch/vertebra foramen costotransversarium" (45 %), " bifurcated vertebral center" (14 %) and "cervical rib" (65 %) as well as "excessive sublingual neuropore" (50 %), all of which malformations having no or little relevance in the other group except of "atresia foramen" with about 25 % in the control and about 4 to 8 % in the other exposure groups
- Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Only after intra-uterine exposure to 5000 ppm: About 50 % of the fetuses with ventricular septal defects (visceral malformation in 16/20 litters or 64/131 fetuses) vs. 0% or near 0% in all other groups, and residual thymus (variation in all 20 litter or 70/131 fetuses) vs. about 2.4 to 2.9 % in 4 litters each of all other groups.
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- After 5000 ppm, food and drinking water consumption of dams was reduced also after birth during lactation. Slight retardation of growth was still significant at weaning. Water consumption was slightly reduced, in particular for females.
Early indicators for post-natal development:
In pups from the 5000-ppm group, eruption of upper incisor and opening of eyelid for both sexes and descensus testis for males were significantly earlier than in the controls in relation to term of delivery, but not in relation to the whole gestation time which was prolonged for this group. There were no differences in behavioral and functional tests as compared to control and other test groups. At the age of 8 weeks, brain, thyroid (males), thymus and testis (males) weights were lower (p<0.01), and pituitary-gland weight of males was higher (p<0.05). But histological examination revealed no treatment-related changes. 16.5 % of the offsprings (15/91 in 8/12 litters) had hemilateral thyroprivia (missing thyroid lobe, mostly left). There was no histopathological lesion in the tissue. The defect was attributed to an impairment of organogenesis.
Reproductive performances of F1 (from 5000 ppm):
No significant effects on sexual cycle, genital function and reproductive performance of the F1 progeny were noted.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1.33 mg/L air
- Basis for effect level:
- other: teratogenicity
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 6.65 mg/L air
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: visceral and skeletal malformations, postnatal growth and survival
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 6.65 mg/m³ air
- Treatment related:
- yes
Any other information on results incl. tables
Note: Exposure per day was >20 h, which implies that prolonged steady-state blood levels were reached which even may have been higher than in studies using the same exposure concentration, but shorter exposure times.
Applicant's summary and conclusion
- Executive summary:
The exposure to 5000 ppm of pregnant rats during gestation (>20 h/d) produces maternal toxicity, fetal malformation, increased perinatal mortality and developmental delay in surviving progeny. Teratogenic effects occurred only at maternally toxic exposure concentration. Exposure levels of 1000 ppm or less did not induce toxic symptoms in maternal animals, structural abnormalities or delay in growth or functional development in the F1-generation. Therefore, the NOEC for maternal and developmental toxicity is considered to be 1000 ppm.
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