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EC number: 225-193-0 | CAS number: 4707-47-5
- 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: OECD TG 401: > 5000 mg/kg bw.
Acute dermal toxicity: OECD TG 402: > 5000 mg/kg bw
Acute inhalation: no adverse effects predicted based on low oral toxicity, low vapour pressure and the substance has a minor respirable fraction (ca. 5%).
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:
- 15 February, 1980 - 29 February, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study is not conducted under GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- No details on test material, no purity, no details on environmental conditions.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Albino (TacN (SD) fBR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms (Germantown, N.Y.)
- Age at study initiation: Young adults
- Weight at study initiation: males: 160 - 200 g; females: 188 - 210 g
- Fasting period before study: Overnight
- Housing: Singly housed in wire cages
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to water
- Acclimation period: Seven days
ENVIRONMENTAL CONDITIONS
No data. - Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.0 mL/100 g body weight
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy of survivors performed: yes, the animals were killed using ether inhalation. - Statistics:
- Not performed.
- Preliminary study:
- Two fasted rats (one of each sex) received a dose of 5000 mg/kg bw. There were no deaths over the 72 hour observation period.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: There were no pharmacotoxic signs in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period.
- Gross pathology:
- There were no signs indicative of toxicity in any of the ten animals necropsied at termination.
- Interpretation of results:
- other: not classified
- Remarks:
- According to EU CLP (EC 1272/2008 and its amendments_.
- Conclusions:
- The acute oral toxicity test showed an LD50 of >5000 mg/kg bw.
- Executive summary:
In this study performed equivalent to OECD TG 401 guideline without GLP, 20 rats (10 males and 10 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred. There were no toxicological otoxic signs in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period. The animals all gained weight in a normal pattern. There were no signs indicative of toxicity in any of the ten animals necropsied at termination. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
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:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- 04 March, 1980 - 18 March,1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study is not conducted according to GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- No details on test material, no purity, no details on environmental conditions, test site not covered.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Albino (Sprague-Dawley CD strain)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Labs (Wilmington, Mass.)
- Age at study initiation: Young adults
- Weight at study initiation: Males: 205 - 252 g; Females: 188 - 212 g
- Housing: Singly housed in wire cages
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to water
- Acclimation period: Seven days
ENVIRONMENTAL CONDITIONS
No data. - Type of coverage:
- open
- Vehicle:
- ethanol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The site of application was approximately that area bounded by the nape of the neck, the mid dorsum between pectoral and pelvic girdles and the lateral aspects of the scapulae.
- % coverage: Judged to comprise less than 30%
- Type of wrap if used: None, open.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None, any excess material was removed by wiping with a clean cloth.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 mL/100 g body weight
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 8
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy of survivors performed: yes, the animals were killed using ether inhalation. - Statistics:
- Not performed.
- Preliminary study:
- Two rats (one of each sex) received a dose of 5000 mg/kg bw. There were no deaths over the 72 hour observation period.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: There were no clinical signs of toxicity in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period.
- Gross pathology:
- There were no signs indicative of toxicity in any of the animals necropsied at termination.
- Interpretation of results:
- other: not classified
- Remarks:
- According to Regulation (EC) No. 1272/2008.
- Conclusions:
- The acute dermal toxicity test showed an LD50 of >5000 mg/kg bw.
- Executive summary:
In this study performed equivalent to OECD TG 402 guideline without GLP, 16 rats (8 males and 8 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred.
There were no clinical signs of toxicity in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period.
The animals all gained weight in a normal pattern. There were no signs indicative of toxicity in any of the animals necropsied at termination.
The acute dermal LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw and the substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2000 and GHS.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute dermal toxicity result is of sufficient quality and adequate for this dossier.
Additional information
Acute oral toxicity:
In this study performed equivalent to OECD TG 401 guideline without GLP, 20 rats (10 males and 10 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred. There were no toxicological signs in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period. The animals all gained weight in a normal pattern. There were no signs indicative of toxicity in any of the ten animals necropsied at termination. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.
Acute inhalation:
Acute inhalation is not expected in absence of acute oral toxicity > 5000 mg/kg bw even when there would be some inhalation exposure. In addition, the substance is a solid and contains a minor particle size fraction of < 10 um (5.3% ) based on which the respirable fraction is minor. Also based on vapour pressure of 0.002 Pa inhalation exposure is not expected (< 0.01 Pa).
Acute dermal:
In this study performed equivalent to OECD TG 402 guideline without GLP, 16 rats (8 males and 8 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred. There were no clinical signs of toxicity in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period. The animals all gained weight in a normal pattern. There were no signs indicative of toxicity in any of the animals necropsied at termination. The acute dermal LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.
Justification for classification or non-classification
The substance does not have to be classified for acute toxicity by the oral, inhalation and dermal route according to EU CLP (EC No. 1272/2008 and its amendments).
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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