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EC number: 608-711-3 | CAS number: 32167-31-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (no data on test substance purity, reduced observation period, limited documentation)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Hydroxyethylated 2-butyne-1,4-diol
- EC Number:
- 608-711-3
- Cas Number:
- 32167-31-0
- Molecular formula:
- C4 H6 O2 (C2 H4 O) n, where 1 < n < 4.5
- IUPAC Name:
- Hydroxyethylated 2-butyne-1,4-diol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Golpanol BEO = Golpanol SC 9189
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gassner, Germany
- Mean body weight at study initiation: males 267 g, females 187 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 16% (G/V)
MAXIMUM DOSE VOLUME APPLIED: 15.6 mL/kg bw - Doses:
- 640, 800, 1000, 1250, 1600, 2000 and 2500 µL/kg bw (corresponding to approx. 730, 912, 1136, 1423, 1824, 2280, 2859 mg/kg bw; calculation based on density of 1.14 g/cm³)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Body weight was determined before the beginning of the study for dose calculation.
Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- N/A
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 824 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 730 and 912 mg/kg bw: no deaths occured;
1136 mg/kg bw: 1/10 animals (males: 1/5 animals died 7 days after treatment; females: 0/5 animals died).
1423 mg/kg bw: 1/10 animals (males: 1/5 animals died within 48 hours after treatment; females: 0/5 animals died).
1824 mg/kg bw: 5/10 animals (males: 1/5 animals died within 48 hours after treatment, 3/5 animals were dead at the end of the observation period of 7 days; females: 1/5 animals died within 48 hours after treatment, 2/5 animals were dead at the end of the observation period of 7 days).
2280 mg/kg bw: 5/10 animals (males: 3/5 animals died within 48 hours after treatment, 4/5 animals were dead at the end of the observation period of 7 days; females: 1/5 animals died within 48 hours after treatment, 1/5 animals were dead at the end of the observation period of 7 days).
2859 mg/kg bw: 10/10 animals (males: 2/5 animals died within 24 hours after treatment, 5/5 animals died within 48 hours after treatment; females: 2/5 animals died within 24 hours after treatment, 5/5 animals died within 48 hours after treatment). - Clinical signs:
- other: On the first study day accelerated respiration, crouched position, reddened, partly closed eyes. On the following observation days crouched position, partly abdominal position, intermittent breathing and reddened eyes. After the 5th day no symptoms.
- Gross pathology:
- Perished animals: 1136, 1423, 1824, 2280 mg/kg bw: kidney and liver: acute congestive hyperemia; dilatation of the heart; thymic petechiae; slight lung edema; liver: loam-yellow-grey with peripheral lobular pattern (peripheral fatty degeneration, necroses).
Sacrificed animals: no abnormalities were noted at necropsy of animals sacrificed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Executive summary:
The non-GLP acute oral toxicity study was performed according to a standardized BASF test protocol. In principle this test protocol is similar to the the OECD Guideline 401: Wistar rats (5/sex/dose) were administered a single oral dose (gavage) of the test item (analytical purity: unknown) at dose levels of 640, 800, 1000, 1250, 1600, 2000 and 2500 mg/kg body weight (bw). The test item was applied as aquaeous solution at a concentration of 16% w/v and at a maximum dose volume of 15.6 mL/kg bw.
The animals were observed for a post-dosing period of 7 days. Subsequently, all surviving animals were killed and like animals that died during the study subjected to gross pathology.
Mortality occurred in the high dose group within 24 hours after application of the test item and symptoms reported were described as accelerated respiration, crouched position, reddened, partly closed eyes. On following observation days crouched position, partly abdominal position, intermittent breathing and reddened eyes were observed. From the 6th day of observation animals were without findings.
No data were available on body weight gain. Gross necropsy findings in rats that died included acute congestive hyperemia, dilatation of the heart, thymic petechiae, slight lung edema, loam-yellow-grey liver with peripheral lobular pattern. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
The acute oral toxicity study is acceptable (reliability 2), though not fully compliant with the actual guideline requirements for an oral toxicity test (OECD 401) in rats (incomplete characterisation of the test substance - purity not given in the study report, observation period shortened - 7 instead of 14 days).
Under the conditions of the study the LD50 of the test item after oral application was determind to be 1824 mg/kg bw.
Classification of the test item for acute oral toxicity as Xn, R22 according EU Directive 67/548/EC as well as Cat 4, H302, Harmful if swallowed according to the CLP Regulation 1272/2008 is warranted.
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