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EC number: 260-252-4 | CAS number: 56539-66-3
- 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:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: T44-03:Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use(FDA:1966)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methoxy-3-methylbutan-1-ol
- EC Number:
- 260-252-4
- EC Name:
- 3-methoxy-3-methylbutan-1-ol
- Cas Number:
- 56539-66-3
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 3-methoxy-3-methylbutan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): MMB
- Physical state: clear liquid
- Analytical purity: 100%
- Receiced on (date): 10 august 1990
- Lot/batch No.: 023849
- Storage condition of test material: 4°C (refrigerated)
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc.
- Age at study initiation: 72 days (birthday: 20 august 1990; female); 66 days (birthday: 18 feburary 1990; male)
- Weight at study initiation: 196 to 228 g (after day of arrival; female); 242 to 288 g (after day of arrival; male)
- Housing: 1 per stainless steel cage
- Diet (e.g. ad libitum): ad libitum ( certified rodent chow; Ralston purina)
- Water (e.g. ad libitum): ad libitum (reverse osmosis membrane)
ENVIRONMENTAL CONDITIONS
- Temperature: 70 to 78 °F
- Humidity (%): 40 to 70 %
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Solutions of the test article in deionized water were prepared daily during the study. The following concentrations of 3-methoxy-3-methyl-butan-1-ol were preparted: 0, 25, 50, 200 mg/mL
DIET PREPARATION
no details given
VEHICLE
- Concentration in vehicle: 0, 25, 50, 200 mg/mL
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): 023849
- Purity: 100% - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- target concentrations: 12.5; 200 mg/mL
measured average concentrations: 12.33; 196.8 mg/mL
GC (Shimadzu, FID detector); (conducted at Lancaster Laboratories Inc.) - Details on mating procedure:
- - Impregnation procedure:
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: female rats with spermatozoa observed in a vaginal lavage or a copulatory plug observed in situ were considered to be at day 0 of presumed gestation and assigned to individual housing
- All females rats that did not have a confirmed mating date, as well as all female rats that mated but were not assigned to the study, were placed in the general population of the test facility. - Duration of treatment / exposure:
- day 6 through 15 of gestation
- Frequency of treatment:
- once a day
- Duration of test:
- 15 days from 6 to 20 days of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Duration of test: for 15 days from 6 to 20 days of gestation
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily for test duration
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: day 0 and on days 6 through 20 of presumed gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes; day 0 and on days 6 through 20 of presumed gestation
POST-MORTEM EXAMINATIONS: Yes /
- Sacrifice on gestation day #20
- Organs examined: laparaohysterectomic examination and necropsy
OTHER:
half of the foetuses from 0 and 2000 mg/kg bw/day groups were examined for soft tissue abnormalities
half of the foetuses from all groups were examined for skeletal abnormalities - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter - Statistics:
- Dunnet (1955), A multiple comparison procedure for comparing several treatments with a control
Snedecor (1967), variance test for homogeneity of the binomial distribution
Siegel (1956), nonparametric statitistics for the behavioral sciences
Dunn (1964), multiple comparisons using rank sums
Kruskal-Wallis test
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased motor activity, excess salivation, ataxia, muscle flaccidity and loss of righting reflex were observed in the 2000 mg/kg bw/day group.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight gain was reduced at 500 and 2000 mg/kg bw/day
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal food consumption was reduced at 500 and 2000 mg/kg bw/day
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- 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:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- not examined
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- No rats died during the conduct of this study. Decreased motor activity, excess salivation, ataxia, muscle flaccidity and loss of righting reflex were observed in the 2000 mg/kg bw/day group. Reduced weight gain and food consumption were recorded at 250, 500 and 2000 mg/kg bw/day.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- < 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean fetal weight was lower at the highest and maternally toxic dose level of 2000 mg/kg bw/day.
- Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Anogenital distance of all rodent fetuses:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Mean fetal weight was reduced at 2000 mg/kg bw/d. The test material did not cause fetal malformations. The 2000 mg/kg bw/day group had significant increases in the litter and fetal incidences of variations in skeletal ossification of the ribs, sternum and pelvis.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- Dose descriptor:
- LOAEL
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- skeletal: sternum
- skeletal: rib
- skeletal: pelvic girdle
- Description (incidence and severity):
- An increase in the incidence of fetal skeletal variations was observed in the ribs, sternum and pelvis at the highest (and maternally toxic) dose level of 2000 mg/kg bw/day.
Overall developmental toxicity
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 2 000 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Any other information on results incl. tables
NOEL for pregnant females: Less than 250 mg/kgbw/day
NOEL for development of fetuses: 500 mg/kgbw/day
Clinical signs: Decreased mortor activity, excess salivation, ataxia, muscle flaccidity and loss of righting reflex were observed in the 2000 mg/kgbw/day group.
Body weights: Decreases of body weight gains in pregnant females of 250, 500 and 2000 mg/kg bw/day.
Food consumption: The 250, 500 and 2000 mg/kg bw/day groups had significant reductions in absolute (g/day) and
relative (g/kg/day) maternal feed consumption values for the entire dosage period.
Necropsy: No gross lesions were caused by the test material.
Fetal parameters: The 2000 mg/kgbw/day group reduced fetal body weight. No other Caesarean-sectioning or litter observations were attributable to the test material.
Malformations and variations: The test material did not cause fetal malformations. The 2000 mg/kgbw/day group had
significant increases in the litter and fetal incidences of variations in skeletal ossification of the ribs, sternum and pelvis.
Applicant's summary and conclusion
- Conclusions:
- A well reported study conducted according to generally accepted scientific standards and in accordance with GLP reported maternal toxicity (increased incidences of clinical observations, and decreases in body weight gain and food consumption) at 500 and 2000 mg/kg bw/day. The occurrence of maternal toxicity was accompanied by fetal toxicity (reduced fetal body weight and significant increases in the litter and fetal incidences of variations in skeletal ossification of the ribs, sternum and pelvis at 2000 mg/kg bw/day). No significant maternal or developmental effects were observed at 250 and 500 mg/kg bw/day, respectively. The maternal NOEL was 250 mg/kg bw/day and developmental NOAEL was 500 mg/kg bw/day.
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