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EC number: 213-611-4 | CAS number: 994-05-8
- 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-methoxy-2-methylbutane
- EC Number:
- 213-611-4
- EC Name:
- 2-methoxy-2-methylbutane
- Cas Number:
- 994-05-8
- Molecular formula:
- C6H14O
- IUPAC Name:
- 2-methoxy-2-methylbutane
- Details on test material:
- - Name of test material (as cited in study report): TAME
- Physical state: clear colourless non-viscous liquid
- Analytical purity: 94.5% by gas chromatography (CG-FID)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at start of study: 6-8 weeks
- Weight at study initiation: 200-250 gram (males); 150-200 gram (females)
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- dosage by gavage at a dose volume of 2 ml/kg
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- once per day, 7 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.125, 0.5, 1.0 g/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
Examinations
- Observations and examinations performed and frequency:
- Rats were observed daily for clinical sings and body weight prior to the first dosing and weekly thereafter. Food consumption was measured weekly. Haematology and clinical chemistry parameters were determined from the blood sample collected at necropsy.
- Sacrifice and pathology:
- Organ weights were measured for the kidneys, adrenals, liver, testes and ovaries. These organs together with the heart and spleen from the control and high-dose group were microscopically examined and any tissues appearing abnormal (as well as these organs from animals that died during the study).
- Statistics:
- Data from the treated groups were compared to those of the control group using the following tests. Comparisons were limited to within sex analysis. Bartlett's test of homogeneity of variance was used to determine if the groups had equivalent variance at the 1% level. If the variances were not statistically different, the groups were computed using a standard one-way analysis of variance. If significant differences among the means were indicated, Dunnett's test was used to determine which treatment groups differed from controls. Where groups did not have equivalent variance, the non-parametric Kruskall-Wallis test was used to assess differences in group means. If the means were different, Dunn's rank test was used to determine which treatment group differed from control.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Four animals died in the high dose group. The deaths occurred between the days 6 and 9 and two of them were presumed test material related, although the precise cause of death was not identified.
The majority of animals did not exhibit unusual clinical signs during the experiment. Lung rales and anogenital staining was observed at low frequency in 1000 mg/kg animals.
Mean body weights were significantly lower in the 1000 mg/kg males on 7 (-14%), 21 (-18%) and 28 (-19%). Females had mean body weights comparable to controls. Food consumption was significantly lower in the 1000 mg/kg males and females during week 1 and also during week 2 in the 1000 mg/kg males.
A dose-related increase of relative (body) and absolute adrenal weight was noted and it was statistically significant in the 500 (mid) and the 1000 (high) mg/kg males. The following mean adrenal weights were measured (grams): ctrl: 0.057 ± 0.010, 125 mg/kg: 0.074 ± 0.015, 500 mg/kg: 0.082 ± 0.008*, 1000 mg/kg: 0.100 ± 0.010** (*p<0.05, **p < 0.01). The mid and high dose males also had increased relative kidney weights. The organ weight increases in the kidney and adrenals were not accompanied by any histopathological changes. The liver weights were not statistically significantly affected. Females displayed no statistically significant differences in any organ weights.
The high dose males had increased activated partial thromboblastin time and increased blood glucose but the biological significance of these findings was unknown.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: adrenal (absolute and relative) and kidney (relative) weight increase
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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