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EC number: 601-601-6 | CAS number: 119345-04-9
- 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 and dermal toxicity data on the registered substance, DOWFAX
2A1, indicate that GHS criteria for classificaiton are not met.
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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guideline/s and GLP, but the report contains sufficient data for interpretation of study results.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Observations and body weights were recorded over a 2-week period following dosing.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- 2000 mg/kg of the neat test material by single-dose oral gavage
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Observations and body weights were recorded over a 2-week period following dosing.
- Statistics:
- None
- Preliminary study:
- None
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: Clinical signs indicative of systemic toxicity in the 2000 mg/ kg dose level consisted of fecal and urine soiling, salivation, chromorhinorrhea, decreased activity, and thin appearance. The clinical signs were first observed two hours post dose and persis
- Gross pathology:
- None
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- The estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg.
- Executive summary:
A sample of Dowfax 2A1 was submitted by Specialty Chemicals, The Dow Chemical Company, Midland, MI for evaluation of acute oral and dermal toxicity and skin and eye irritation.
In the acute oral toxicity test, three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Clinical signs indicative of systemic toxicity in the 2000 mg/kg dose level consisted of fecal and urine soiling, salivation, chromorhinorrhea, decreased activity, and thin appearance. The clinical signs were first observed two hours post dose and persisted through test day four. While one of these rats initially lost weight, all animals gained weight over the two-week observation period. The estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- acceptable
Acute toxicity: via inhalation route
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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guideline/s and GLP, but the report contains sufficient data for interpretation of study results.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Following exposure, observations and body weights were recorded over a 2-week period.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No additional data
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 male rabbits/dose
- Control animals:
- no
- Details on study design:
- In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat Dowfax 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Following exposure, observations and body weights were recorded over a 2-week period.
- Statistics:
- None
- Preliminary study:
- Not applicable
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.
- Executive summary:
A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a slightly abraded site (minor incision through the stratum corneum of insuffiaent depth to produce bleeding), caused only very slight irritation to the skin, it is felt that these burns may be a result of the procedure used in preparing the animals for testing. These observations were noted through test day four in one animal, and test day eight in the other. By test day eight, both animals were observed with scaling which persisted through the end of the study. Administration of DOWFAX 2A1 at 2000 mg/kg had no apparent effect on body weight during the two-week observation period. The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- acceptable
Additional information
In the studies conducted with DOWFAX 2A1, the acute oral and dermal toxicity were low, with LD50 values in excess of 2000 mg/kg bw, and no deaths were observed. This is also true for the other ADPODS substances relevant for read across, indicating that this particular group of chemicals has a low order of toxicity via the oral and dermal routes (refer to full ADPODS category justification document).
No data are available for inhalation toxicity. However, this is unlikely to be a relevant route for human exposure due to the low vapour pressure and limited possibility for generating a large concentration of aerosol in normal handling conditions.
Justification for selection of acute toxicity – oral endpoint
acceptable limit dose study for the REACH registered substance
Justification for selection of acute toxicity – dermal endpoint
acceptable limit dose study for the REACH registered substance
Justification for classification or non-classification
No classification is required for acute toxicity based on the study outcomes.
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.
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