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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 207-975-3 | CAS number: 503-74-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study Readacross is justified due to the toxicokinetic arguments described within the Endpoint Summary.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- other: Toxicological assessment
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 3-methylbutan-1-ol
- EC Number:
- 204-633-5
- EC Name:
- 3-methylbutan-1-ol
- Cas Number:
- 123-51-3
- IUPAC Name:
- 3-methylbutan-1-ol
- Details on test material:
- Name of test material (as cited in study report): 3-methyl-l-butanol
- Test substance No. 88/56
- Physical state: liquid/colourless
- Analytical purity: 98.6%
- Date of purity test: 1988-02-02
- Stability under test conditions: The stability was ensured for the study period under the specified storage conditions by reanalysis ( see report of Nov 25, 1988)
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- - Source: Dr. K. Thomae GmbH, D-7950 Biberach/Riss, FRG). The animals were free from any clinically evident signs prior to the beginning of the study.
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: approx. 216 g
- Housing: singly in wire cages
- Diet: KLIBA rat/mouse laboratory diet 24-343-4 10 mm pellets, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; during the exposure-free observation period ad libitum
- Water: tap water ad libitum; during the exposure-free observation period
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the animals were exposed singly in wire cages in the whole-body inhalation chambers (volumes ca. 1100 L (test group 1, 2 and 3), and ca. 1600 L (test group 0 and parts of the test groups during the pre-flow period).
- Method of holding animals in test chamber: animals were expose din the wire cages
- Source and rate of air: the test substance was supplied by means of two continuously driven metering pumps to a vaporizer heated with a circulating thermostat. The evaporation temperature was 50-70°C. A measured stream of fresh air took up the vapours and was mixed with another stream of fresh air. After passing through a mixing device, this mixture of vapours and air was supplied to the exposure chamber.
- Temperature, humidity, pressure in air chamber: temperature and pressure in the inhalation chamber was measured continuously (generally 3 times/exposure). The relative humidity was measured at least daily.
- Air flow rate: all air flows, supply air and exhaust air were adjusted by means of flowmeters for all test groups and recorded, as a rule, 6 times/exposure.
TEST ATMOSPHERE
- Brief description of analytical method used: The concentrations of the test groups were analyzed by gas chromatography after absorption of 3-methylbutanol in 2-propanol. The gas chromatograph was calibrated with the test substance.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gas chromatography
- Details on mating procedure:
- - Impregnation procedure:cohoused
- If cohoused:
- M/F ratio per cage: 1:4
- Length of cohabitation: over night
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Gestation days 6 - 15; 6 hours/day
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.5, 2.5 and 10 mg/L
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.51±0.02, 2.50±0.17,and 9.8±0.66 mg/L
Basis:
analytical conc.
GC
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of a pilot study. Doses up to 5 mg/L caused no toxicity in females.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least daily
BODY WEIGHT: Yes
- Time schedule for examinations: on gestation days 0, 3, 6, 9, 12, 15, 18, and 20
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20.
- Organs examined: uterus, ovaries, placenta - 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: all per litter
- Skeletal examinations: Yes: - Statistics:
- DUNNETT's test, Fisher's exact test
- Indices:
- The folowing indices were calculated:
- conception rate ( %;): (number of pregnant animals/ number of fertilized animals)*100
- preimplantation loss (%): (number of corpora lutea - number of implantations/number of corpora lutea)*100
- postimplantation loss (%): (number of implantations - number of live fetuses/number of implantations)*100 - Historical control data:
- yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: marginal body weight retardation at 10 mg/L
Details on maternal toxic effects:
Transient marginal body weight reduction at 10 mg/L at beginning of the study
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 2.5 mg/L air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 10 mg/m³ air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects. Remark: at any dose level
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- 10 mg/L air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In an OECD 414 study (inhalation, rats) , 3-methylbutanol caused marginal maternal toxicity but no toxicity to reproduction (development, teratogneicity).
- Executive summary:
The toxicity of 3-methylbutanol to reproduction was examined in Wistar rats (25 females per dose; whole body inhalation exposure at 0, 0.5, 2.5, and 10 mg/L; gestation days 6-15, 6 hours per day) according to OECD 414 and under GLP conditions. No maternal or developmental toxicity was noted in a pre-test at 5 mg/L.
In the main study, maternal toxicity was limited to a transient marginal body weight retardation at the start of the exposure period. Reproduction parameters were not affected at any dose. There was no effect regarding viability, development and malformations noted in the fetuses. The NOAEC for maternal toxicity was 2.5 mg/L, the NOAEC for developmental toxicity and teratogenicity was 10 mg/L, the highest tested dose (Klimisch, 1990).
Since 3-methylbutanol is rapidly oxidised to isovaleric acid, this result can be transferred to isovaleric acid. In this context it could be further noted that the same result (NOAEC 2.5 mg/L for the maternal organism and 10 mg/L for the foetal organism) was obtained in a GLP OECD 414 inhalation study with white Himalayan rabbits (15 dams/group; 0.5, 2.5, and 10 mg/L; gestation days 6-19, 6 hours/day; Klimisch and Hellwig, 1990). These results are suitable for the assessment of isovaleric acid.
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.