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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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: LD50 (rat;male/female) > 2000 mg/kg bw / day
Acute inhalation toxicity: No study available
Acute dermal toxicity: LD50 (rat; male/female) > 2000 mg/kg bw / day
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-05-30 TO 2010-07-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD technical guideline 423 - Acute Oral Toxicity study following GLP with no deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- 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: 190-200g females, 240-290g 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: 21 July 2010 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Aqua pro inujectione (Imuna), Lot 0621VA - H2O
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: undiluted
- Lot/batch no. (if required): Lot 0621VA - H2O
MAXIMUM DOSE VOLUME APPLIED: 0,674 ml
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on the low acute toxicity of the main identified constituent 2-ethylhexanol. - Doses:
- Fixed dose 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, periodically during first 24 hours (first 4 hours), daily until 14 days. Body weights measured weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- No toxicity observed.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The substance was recognized as orally non-toxic up to 2000 mg/kg bw in a well-established study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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.
- 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
- 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 - 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
- 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity
There is available an acute oral toxicity study for the target substance by Hameln r.d.s (2010). The study was conducted according to the OECD 423 guideline and according to GLP. An acute limit oral testing exhibited no toxicity up to 2000 mg/kg bw.
Testing via inhalation route cannot be considered a risk due to low vapour pressure of the substance and thus would have required most probably generation of aerosols to derive effect levels. Therefore acute inhalation toxicity is not considered relevant for workers or general population, but is taken qualitatively account for elevated temperatures (chapter 9 of CSR).
There is available an acute dermal toxicity study for the target substance by Hameln r.d.s (2010). The study was conducted according to the OECD 402 guideline and according to GLP. An acute limit dermal testing exhibited no toxicity up to 2000 mg/kg bw.
Aspiration toxicity
Based on the dynamic viscosity at 40 deg. C and the density of the substance (851.3 kg/m3), the kinematic viscosity is calculated to be 2.784 mm2/s. As the target substance is a hydrocarbon and the calculated kinematic viscosity is less than 20.5 mm2/s, the substance may cause aspiration hazard.
Justification for selection of acute toxicity – oral endpoint
Reliable, guideline compliant study conducted for the target substance.
Justification for selection of acute toxicity – inhalation endpoint
The target substance does not cause a concern for acute inhalation toxicity due to low vapor pressure at room temperature.
Justification for selection of acute toxicity – dermal endpoint
Reliable, guideline compliant study conducted for the target substance.
Justification for classification or non-classification
Based on the well established acute tests of the target substance, there is no need to classify the substance for acute health hazards according to CLP Regulation 1272/2008 and according to Directive 67/548/EEC.
Based on the kinematic viscosity of the target substance (2.784 mm2/s) measured at 40 °C, the substance is classified for Asp.Tox. 1. according to CLP Regulation 1272/2008 and for Xn; R65 according to Directive 67/548/EEC.
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