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Diss Factsheets
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EC number: 948-047-4 | CAS number: -
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 December 1991 - 27 December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 401 (Acute Dermal Toxicity)
- Version / remarks:
- February 1987
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 927-763-0
- Cas Number:
- 853947-59-8
Constituent 1
- Specific details on test material used for the study:
- Batch number: 12430
General characteristics: Odourless oily liquid
Purity: Butanediol dioctanoate: 36.3 (% by area); Butanediol octanoate decanoate: 46.3 (% by area); Butanediol didecanoate: 15.1 (% by area)
Storage conditions: In a closed container in a laboratory hood
Stable until: 06/1993
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Body weight of animals at start of test: 200-300 g
Room temperature: 20±3°C
Rel humidity: 30-70%
Acclimitisation: At least 5 days
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The volume administered was 2.2 cm3/kg bw
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- not specified
- Details on study design:
- The animals were examined for clinical signs 1/2, 1, 2, 3, 4, 5 and 6 hours after administration and once a day for the next two weeks. The relevant area was examined for dermal reactions related to the test substance. The time of occurrence and the nature of the signs were recorded separately for each animal. The animals were weighed on the day of administration (day 0), on day 7 and at the end of the test (day 14). After the observation period of 14 days, all the animals were sacrificed by inhalation of carbon dioxide, necropsied and inspected for macroscopic changes to organs. The necropsy results were recorded separately for each animal.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities during the study.
- Clinical signs:
- other: No signs of toxicity related to the substance were found with the dose of 2000 mg/kg bodyweight during the 14-day observation period.
- Gross pathology:
- The necropsies at the end of the study revealed no macroscopic changes to organs, nor were there any abnormalities in the skin and subcutaneous tissue in the application area.
- Other findings:
- The animals showed no dermal reactions 24 hours after administration and up to the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 is greater than 2000 mg/kg bw.
- Executive summary:
In an acute toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) by semi occlusive dermal application at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The dermal LD50 is greater than 2000 mg/kg bw.
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