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Diss Factsheets
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EC number: 203-905-0 | CAS number: 111-76-2
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline GLP study with full report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- , use of guinea pigs
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-butoxyethanol
- EC Number:
- 203-905-0
- EC Name:
- 2-butoxyethanol
- Cas Number:
- 111-76-2
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-butoxyethanol
- Details on test material:
- - Name of test material (as cited in study report): 2-butoxyethanol
- Physical state: liquid
- Analytical purity: 99.8%, analysis by GC/FID
- Lot/batch No.: 9792
- Stability under test conditions: Samples analysed at start and finish of study and found to be identical.
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, NY
- Age at study initiation: 5-7 weeks
- Weight at study initiation: males: 309-405g. Females: 310-375
- Fasting period before study: overnight
- Housing: individual, stainless steel mesh cages
- Diet (ad libitum): Agway Prolab animal diet RMH3000
- Water (ad libitum: tap (Monroe County water authority.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 69-72 deg F
- Humidity (%): 57-59%
- Photoperiod (hrs dark / hrs light): 12/12hrs
IN-LIFE DATES: From: 1/3/94
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10%, 20%, 40%. Measured to be 42.5%, 18.2% and 10.1% (wt/vol) mean
- Amount of vehicle (if gavage): 1.5 - 2.0ml
- Purity: distilled
MAXIMUM DOSE VOLUME APPLIED: 2.03ml - Doses:
- 500, 1000, 2000mg/kg nominal
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 3 times on day of dosing, daily thereafter.
- frequency of weighing: days 0, 7, 14
- Necropsy of survivors performed: yes (and on those dying early.)
- Other examinations performed: clinical signs, body weight, gross pathology. - Statistics:
- Mean and standard deviation
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 414 mg/kg bw
- 95% CL:
- > 1 020 - < 1 961
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 500 mg/kg bw
- Mortality:
- Low dose: none
Mid dose: 1 out of 5 of each sex (deaths by day 3)
High dose: 3/5 males, all females (deaths within 1 day) - Clinical signs:
- other: Low dose: Slight weakness on day of dosing only. Mid dose: moderate to severe weakness on day of dosing and prior to death. Male that died on day 3 showed severe weakness, gasping and red nasal discharge. All animals that survived appeared normal follo
- Gross pathology:
- Minor to moderate diffuse necrosis and minimal to minor haemorrhage in the gastric mucosa. Minimal to minor accumulation of mucoid contents in the duodenum.
- Other findings:
- no other significant findings reported.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Substance is a gastrointestinal irritant, as evidenced by sialorrhea, staining of face with food and saliva and treatment related changes to the gastric mucosa. All abnormal clinical signs were either transient or noted prior to death. Substance shows an LD50 of 1414mg/kg
- Executive summary:
A GLP guideline acute oral acute single dose toxicity study was performed in male and female guinea pigs and established an LD50 of 1414mg/kg across the two sexes. Those animals that did not die fully recovered from any adverse clinical effects within 6 days, even at the highest dose tested of 2000mg/kg. It was concluded that the substance is a gastrointestinal irritant, as evidenced by sialorrhea, staining of face with food and saliva and treatment related changes to the gastric mucosa but there was no evidence of any adverse effects on the red blood cells, suggesting that the species is resistant to such effects. Based on the results of this study, this substance would be classified 'harmful' for acute toxicity in accordance with the current EU guidelines GHS regulation, although this is not a preferred species for testing. Under the EH GHS classification regulation, it would be classified category 4.
Synopsis
Oral LD50 (guinea pig) = 1414mg/kg
Oral single dose NOAEC (guinea pig) = 500mg/kg
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