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EC number: 402-130-7 | CAS number: 106246-33-7
- 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:
The study was performed 1988 as GLP-test following EU-testing method B.1. A pretest (screening) with five groups of 1 male & 1 female per dose level (250, 500, 1000, 2000 and 5000 mg/kg) was performed as DRF-study. The used species were Wistar rats. In the main study, 5 males and 5 females were treated with a single dose of 5000 mg/kg. The test item was dissolved in 1% aqueous methyl cellulose. One male died on day 8 after showing clinical symptoms. Necropsy examination of this animal showed effects in several organs. The remaining animals shower neither clinical signs nor effects on organs. In conclusion, the acute oral LD50 on both sexes was determined to be > 5000 mg/kg.
Acute inhalation toxicity:
Based on the low amount of inhalable particles (< 10 µm) of less than 10% and the use of the substance, the potential for the generation of inhalable forms is low, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur, and no acute inhalation test was performed.
Acute dermal toxicity:
The study was performed 1986 as GLP-test following EU-testing method B.3. The used species were Sprague-Dawley rats; 5 males and 5 females were treated with a single dose of 2000 mg/kg. The test item was moistened with distilled water and applied by occlusive dressing. Neither clinical signs nor effects on organs were noted. Body weight gains were lower than expected, particularly in females.
In conclusion, the acute dermal LD50 was determined to be > 2000 mg/kg.
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:
- February 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under storage conditions: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: stable - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Weight at study initiation: Males 256 - 289 g; females 204 - 231 g.
- Fasting period before study: overnight fast prior to dosing
- Housing: groups of 5 by sex in grid floor stainless steel cages
- Diet: SQC Rat and Mouse Maintenance Diet No. 1, Expanded; Specia1 Diets Services Ltd., Witham
- Water: Mains water was provided at all times and dispensed from glass water bottles
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25°C
- Humidity: 40 - 70%
- Air changes: 10 changes /hour; single air-conditioned room
- Photoperiod: 12 hours darkness; 12 hours fluorescent lightning - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% aqueous methyl cellulose
- Details on oral exposure:
- The test article preparations were administered once only by oral gavage using a metal stomach tube attached to a disposable plastic syringe.
- Doses:
- PRETEST (SCREENING):
- Dose levels of 250, 500, 1000, 2000 and 5000 mg/kg; 2 fasted rats (1 male and 1 female) per dose group
MAIN STUDY (LIMIT TEST):
- Single dose level of 5000 mg/kg; 10 fasted rats (5 males, 5 females} - No. of animals per sex per dose:
- PRETEST (SCREENING):
- Five groups of 1 male & 1 female per dose level (250, 500, 1000, 2000 and 5000 mg/kg)
MAIN STUDY (LIMIT TEST):
- Group of 5 males & 5 females at a dose level of 5000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Frequency of observations and weighing:
All animals were observed for overt signs of toxicity or behavioural changes at 15 min, 1, 2 and 4 hours after -treatment and subsequently once daily for 14 days. All observations were recorded. Individual body weights were recorded on the day before treatment (day-1), on the day of treatment, on days 7 and 14 or at death. - Preliminary study:
- The male animal receiving 5000 mg/kg died during this study. The oral LD50 was considered to be in excess of 5000 mg/kg.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- MALES:
- 5000 mg/kg bw: One male out of five was found dead on day 8. No other deaths were noted.
FEMALES:
- 5000 mg/kg bw: No mortality observed in females. - Clinical signs:
- other: All animals appeared normal on the day of dosing and up to 5 days after treatment. On days 6 and 7, one male appeared emaciated with hunched posture and staining to the body. This animal was found dead on day 8. All other animals continued to appear norma
- Gross pathology:
- The male which died during the study was emaciated and at necropsy showed dark lungs and enlarged liver which also appeared pale w ith dark and yellow patches. All animals necropsied at termination were unremarkable.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 on Wistar rats (males and females) was found to be > 5000 mg/kg.
- Executive summary:
The study was performed 1988 as GLP-test following EU-testing method B.1. A pretest (screening) with five groups of 1 male & 1 female per dose level (250, 500, 1000, 2000 and 5000 mg/kg) was performed as DRF-study.
The used species were Wistar rats. In the main study, 5 males and 5 females were treated with a single dose of 5000 mg/kg. The test item was dissolved in 1% aqueous methyl cellulose. One male died on day 8 after showing clinical symptoms. Necropsy examination of this animal showed effects in several organs. The remaining animals shower neither clinical signs nor effects on organs.
In conclusion, the acute oral LD50 on both sexes was determined to be > 5000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Klimisch 1; guideline study
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
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Based on the low amount of inhalable particles (< 10 um) of less than 10% and the use of the substance, the potential for the generation of inhalable forms is low, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.
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:
- September 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under storage conditions: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: stable - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age: 6 - 8 weeks
- Weight at study initiation: 215 - 305 g
- Housing: groups of 5 by sex in suspended polypropylene cages
- Diet: Special Diet Services Expanded Rat and Mouse Maintenance Diet No. 1
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23°C
- Humidity: mean 51% - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- The test material, at a dose level of 2000 mg/kg, was applied evenly onto the prepared gauze dressing and wetted with distilled water. The dressing was then applied to the shaved back of each rat with approximately 10% of the body surface in contact with the test material. The trunk of the rat was then encircled with a strip of non-irritating tape (Sleek).
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Each rat was individually housed for a contact period of 24 hours following application, after which the dressing was removed and the skin wiped with a damp tissue to remove excess material. The rats were then returned to their original cages. The rats were observed frequently on the day of dosing and for 14 days following dosing. They were weighed immediately prior to dosing, 7 days after dosing and at death or sacrifice at the end of the 14 day
observation period. At death or at the end of the observation period and sacrifice by nitrogen asphyxiation, each animal was subjected to a gross post mortem.
- ; - Preliminary study:
- no pre-test performed
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- MALES:
- 2000 mg/kg bw: No mortality observed in males.
FEMALES:
- 2000 mg/kg bw: No mortality observed in females - Clinical signs:
- other: No deaths and no clincal signs of toxicity observed.
- Gross pathology:
- No effects on organs observed.
- Other findings:
- No signs of local toxicity observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 on Sprague-Dawley rats (both sexes) was found to be > 2000 mg/kg.
- Executive summary:
The study was performed 1986 as GLP-test following EU-testing method B.3. The used species were Sprague-Dawley rats; 5 males and 5 females were treated with a single dose of 2000 mg/kg. The test item was moistened with distilled water and applied by occlusive dressing. Neither clinical signs nor effects on organs were noted. Body weight gains were lower than expected, particularly in females.
In conclusion, the acute dermal LD50 was determined to be > 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 1; guideline study
Additional information
Justification for classification or non-classification
Based on the data available, the substance is not classified or labelled according to Regulation 1272/2008/EC (CLP).
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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