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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 230-991-7 | CAS number: 7397-62-8
- 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
- Study period:
- February 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Sufficient data for assessment considering the date of study report
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- no guideline available
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Observation period only 7 days
- Principles of method if other than guideline:
- LD50 calculated according to the method of Kaerber
- GLP compliance:
- no
- Remarks:
- Study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Butyl glycollate
- EC Number:
- 230-991-7
- EC Name:
- Butyl glycollate
- Cas Number:
- 7397-62-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- butyl glycolate
- Reference substance name:
- Polysolvan O
- IUPAC Name:
- Polysolvan O
- Reference substance name:
- Glycolic acid-n-butyl ester
- IUPAC Name:
- Glycolic acid-n-butyl ester
- Details on test material:
- - Name of test material (as cited in study report): Polysolvan O (butyl glycollate)
- Physical state: liquid
- Analytical purity: =97 % (Sum of Glycolic acid-n-butylester, Butoxyacetic acid-n-butylester, Diglycolic acid-di-n-butylester calculated as Glycolic acid-n-butylester)
- Impurities (identity and concentrations): chloro acetic acid n-butyl ester (>0.3% ), glycolic acid (>0.3%), water (>0.3), n-butanol (max. 2%)
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 94 - 124 g (mean 108 g)
- Fasting period before study: 12 h
- Housing:
- Diet: ad libitum (Altromin R, company Altromin, Lage, Germany, exception fasting period)
- Water: tap water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% - Doses:
- 2500, 4000, 5000, 6300, 10000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes - Statistics:
- None required
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 595 mg/kg bw
- Mortality:
- 2500 mg/kg bw: 0/10
4000 mg/kg bw: 2/10
5000 mg/kg bw: 7/10
6300 mg/kg bw: 10/10
10000 mg/kg bw: 10/10
Deaths occurred within 1 - 24 hours after application - Clinical signs:
- other: Apathy prior to deaths
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In an acute oral toxicity study, groups of fasted female Wistar rats (10/group) received a single oral dose of Polysolvan O (butyl glycollate, 97%) as 25% solution in sesame oil at dose levels of 2500, 4000, 5000, 6300, 10000 mg/kg bw and were observed for 7 days. The LD50 was determined according to the method of Kaerber.
Beside apathy prior to deaths, there were no treatment related clinical signs and no findings at necropsy. Deaths occurred within 1 – 24 hours and were restricted to the dose levels of 4000 mg/kg bw and above. None of the animals died at 2500 mg/kg bw, a dose level above the current requirement for a limit dose.
LD50-value was 4595 mg/kg bw
Thus, Polysolvan O (butyl glycollate, 97%) is of low acute oral toxicity based on the LD50value.
Classification and labelling is not required.
Conclusion:
Polysolvan O (butyl glycollate, 97%) was tested for acute oral toxicity in a valid test comparable to OECD Guideline No. 401. The oral LD50 value was 4595 mg/kg bw in female Wistar rats.
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.