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Diss Factsheets
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EC number: 203-786-5 | CAS number: 110-63-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute toxicity of 1,4-butanediol in laboratory animals.
- Author:
- Jedrychowski et al.
- Year:
- 1 990
- Bibliographic source:
- Polish Journal of Occupational Medicine 3, (4), 415 - 420
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, et. al., J Pharm Exp Ther 82, 377-390, 1994
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Butane-1,4-diol
- EC Number:
- 203-786-5
- EC Name:
- Butane-1,4-diol
- Cas Number:
- 110-63-4
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,4-diol
- Details on test material:
- above 98%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- White Vienna rabbits, body weight 3 .4 - 3 .8 kg, housed individually, were used to assess dermal irritation. Food (LSK, Plant, Motycz, Poland) and water were provided ad libitum.
TEST ANIMALS
- Source: Nofer Institute of Occupational Medicine husbandry
- Age at study initiation: no data
- Weight at study initiation: 3.4-3.8 kg
- Housing: Housed individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 55-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved and abraded
- Remarks:
- intact (right side) and abraded (left side) skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent no treatment
- no
- other: Adjacent areas of untreated and water-treated skin of each animal served as a control for the test.
- Amount / concentration applied:
- 0.3 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours after patch removal.
- Number of animals:
- 4
- Details on study design:
- Fur from the side-areas of the trunk of all the rabbits was removed by cIipping and shaving to facilitate test material application. The gauze patches (2 x 2 cm) with 0.3 ml undiluted BAD (1,4-butanediol) were applied to the intact (right side) and abraded (left side) skin of animals. Adjacent areas of untreated and water-treated skin of each animal served as a control for the test. The patches were covered with plastic foil and protected by means of a suitable occIusive dressing for the 24 hrs exposure period. Observations for dermal irritation were made 1, 24, 48 and 72 hrs after patch removal. Dermal evaluation utilized the scoring system of Draize et al. Dermal irritancy ratings were determined using the cIassification system as folIows: slightly irritating < 2, moderately irritating 2 - 5, severely irritating > 5. The rabbits were used to assess short-term dermal irritation. The same internal areas of the right ears of rabbits were painted with either 100% or 50% BAD (1,4-butanediol) in water solution for 10 consecutive days incIuding weekend. The left ear of each rabbit painted with water served as a control for the test. Observations for dermal irritation were made the day after painting.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No dermal reaction was noted in rabbits with intact or abraded skin after a single 24 hour exposure. There was no skin reaction following short-term (10 consecutive days) dermal exposure to 50% BAD (1,4-butnanediol) in water. Only after 10 days a minimal reddening of the ear skin was observed in 2/4 rabbits treated with undiluted BAD (1,4-butanediol).
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