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EC number: 203-529-7 | CAS number: 107-88-0
- 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
Neurotoxicity
Administrative data
- Endpoint:
- neurotoxicity: acute oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1970
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: publication, insufficient documentation, no validated test procedure
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
- Principles of method if other than guideline:
- acute neurotoxicity
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Butane-1,3-diol
- EC Number:
- 203-529-7
- EC Name:
- Butane-1,3-diol
- Cas Number:
- 107-88-0
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,3-diol
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,3-butanediol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 430 g (test I) to 432 g (test II)
- Diet: access from noon to 3 p.m.
- Water: ad libitum
- Acclimation period: one week (test I); "a period of weeks" (test II)
Administration / exposure
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- TEST I
- single exposure; five different test-items (1,3-butylene glycol, glycerol, water, sucrose, sham-treated) were tested in parallel, rats received a different treatment each day, five days per week for three weeks and in a different order each week
TEST II
- each dose level was presented to each rat over a five-day period - Frequency of treatment:
- TEST I
- on 3 days within 3 weeks
TEST II
- once per day
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
3500
Basis:
actual ingested
test I
- Remarks:
- Doses / Concentrations:
0, 1750, 3500, 5250, 7000 mg/kg bw
Basis:
actual ingested
test II
- No. of animals per sex per dose:
- - test I: 8 males per dose
- test II: 8 males per dose - Control animals:
- yes, sham-exposed
- Details on study design:
- TEST II
- corn oil was added to all except the high dose group to produce a constant caloric value across the dose range of 42 kcal/kg
- in the succeeding study run without caloric filler animals were randomly assigned to an "active" and a "restrained" condition; the active group was run exactly as in TEST I; the restrained group was barred from the wheel during the 3 hrs before feeding
- in test II seven additional rats were re-used which had been used in a preliminary sucrose study
The results of TEST I were confirmed in a third test, which was similar to TEST I, but the administered dose was 7000 mg/kg bw/d. Rats had to balance on a rotating dowel instead of measurement of voluntary activity.
Examinations
- Neurobehavioural examinations performed and frequency:
- - recording of activity in a wheel
- recording the ability to balance on a rotating dowel
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- not specified
- 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):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Details on results:
- TEST I
- rats treated with the test item showed a clearly depressed voluntary activity
- food consumption was reduced, but not statistically significant
- statistically significant reduced water intake during the activity test
- an increased number of falls from the rotating dowel were recorded in the confirmation experiment
- in the confirmation test with the double dose, the test item produced more falls from the rotating dowel than any other substance compared
TEST II
- activity, food and water intake were dose dependently reduced, already at the lowest dose applied
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 1 750 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: decreased voluntary activity after repeated applications on five consecutive days
- Remarks on result:
- other:
Any other information on results incl. tables
TEST I
Effects in the second feeding period might be influenced by the effects of the first feeding period.
TEST II
- activity was dose dependently depressed in treated animals, this effect occurred independently if a fat filler was added to the diet or not.
Applicant's summary and conclusion
- Conclusions:
- Treatment of rats with 1,3-butylene glycol resulted in a reduced voluntary activity of the animals and impaired their ability to balance on a rotating dowel. suggesting that the test item acts as a CNS depressant or strong muscle relaxant.
- Executive summary:
Application of 1,3-butylene glycol to rats once a week on three consecutive weeks or five consecutive days in doses >/= 3500 mg/kg bw/d or >/= 1750 mg/kg bw/d, respectively, resulted in a decreased voluntary activity in rats or impaired ability to balance on a rotating dowel. Food uptake and water intake was also depressed (Ayres and Isgrig, 1970).
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