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EC number: 931-740-0 | 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:
- 2010-05-30 TO 2010-07-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: An acute dermal toxicity study according to OECD technical guideline 402, following GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Distillation residue, butyl alcohols production, rectification
- EC Number:
- 931-740-0
- Molecular formula:
- undefined (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Distillation residue, butyl alcohols production, rectification
- Details on test material:
- A composite sample, consisting of 5 sub-samples taken over a period of 3 consecutive days, was collected directly from the process line. The volume of each sub-sample was approximately 5-10 L. The sub-samples were combined, resulting in a total volume of ca. 50 L. This ca. 50 L composite sample was split into two equal portions of ca. 25 L each (control sample and laboratory sample). The ca. 25 L laboratory sample was further split into two portions of ca. 5 L and 20 L before sending for analysis at two separate laboratories. After sampling and sample splitting, all the portions of the composite sample were stored at +4 deg Celsius.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Accredited Breeding Velaz Prague Czech Republic
- Age at study initiation: no data
- Weight at study initiation: 190-210g females, 220-290g males
- Fasting period before study: overnight
- Housing: Animals were housed in experimental animal house on the bedding (wooden grate) in groups by maximum of 3 in cage in conformity with laboratory animals welfare legistlation.
- Diet (e.g. ad libitum): ad libitum. A standard certified laboratory diet (supplier Top Dovo, Dobra Voda) was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 2
- Humidity (%): 55 +-10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 30 May 2010 To: 22 July 2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10% of total body surface
- Type of wrap if used: porous gauze patch covered with nonpermeable folio by means of a semi-occlusive dressing and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): fully absorbed
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,440 - 0,670 ml
- Concentration (if solution): undiluted
- Constant volume or concentration used: no, adjusted by body weight
VEHICLE
- Amount(s) applied (volume or weight with unit): undiluted - Duration of exposure:
- 14 days
- Doses:
- Fixed dose 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: first 30 minutes, periodically the first 24 hours and daily until 14 days. Bodyweights measured at the beginning, after one week and the end of the experiment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities.
- Clinical signs:
- other: Tested product applied to 5 male and 5 female rats in limit dose 2000 mg/kg did not cause death either visible symptoms of toxicity during first 4 hours after application or 14 day observation period.
- Gross pathology:
- All 5 males and 5 females had survived observation period and were necropsied after euthanasia. During necropsy no macroscopically changes were noticed.
- Other findings:
- Test compound was fully absorbed without residuum. Any excessive irritation was not observed in the site of application after removing of semiocclusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The substance was recognized as dermally non-toxic up to 2000 mg/kg bw in a well-established study.
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