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EC number: 280-084-5 | CAS number: 82985-35-1
- 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
Oral (similar to OECD TG 401), rat: LD50 = 4200-8400 mg/kg bw (male) and 3780 mg/kg bw (female)
Dermal (similar to OECD TG 402), rabbit: LD50 = 16 800 mg/kg bw (male) and 11 865 mg/kg bw (female)
Inhalation: no reliable data available
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (no data on test material purity is given)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hilltop-Wistar albino rats
- Weight at study initiation: 200-300 g
- Fasting period before study: yes (overnight)
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The test material was administered undiluted, since it reacted quickly with water under formation of a hard mass.
MAXIMUM DOSE VOLUME APPLIED: 16.0 ml/kg bw - Doses:
- - 2.0, 4.0, 8.0, and 16.0 ml/kg bw as stated in the study report
- volumes applied correspond to doses of 2100, 4200, 8400, and 16800 mg/kg bw (converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animal weights were recorded at day 0 (prior to dosing), and at days 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- LD50 was calculated by the moving average method and is based on a 14 days observation period.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 - < 8 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Mortality: 2/5 (16 ml/kg bw); 0/5 (8 ml/kg bw); 2/5 (4 ml/kg bw)
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 200 - < 8 400 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3.6 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.8 - 6.9
- Remarks on result:
- other: Mortaility: 4/5 (16 ml/kg bw); 0/5 (8 ml/kg bw); 3/5 (4 ml/kg bw)
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 780 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 890 - 7 245
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4
- Mortality:
- Males:
- 16.0 ml/kg bw: 2/5 on days 2 and 5
- 8.0 ml/kg bw: 0/5
- 4.0 ml/kg bw: 2/5 on days 3 and 4
- 2.0 ml/kg bw: 0/5
Females:
- 16.0 ml/kg bw: 4/5 on days 1, 2, 2, and 6
- 8.0 ml/kg bw: 0/5
- 4.0 ml/kg bw: 3/5 on days 2, 3, and 8
- 2.0ml/kg bw: 0/5 - Clinical signs:
- other: Males: - 16.0 ml/kg bw: sluggishness at 5 min; unsteady gait at 2 h; prostration at 3 h; red, crusty discolouration on mouth and nose area at 1 day; survivors recovered at 2 days - 8.0 ml/kg bw: sluggishness at 5 min; recovery at 2 h - 4.0 ml/kg bw: gasp
- Gross pathology:
- Males:
- 16.0 ml/kg bw: in animals found dead: lungs dark red; stomachs filled with hard mass; in survivors: lungs dark red; lung of 1 male with white nodules
- 8.0 ml/kg bw: lungs with maroon patchy discolouration
- 4.0 ml/kg bw: in one animal found dead: dark red liver; in survivors: nothing remarkable
- 2.0 ml/kg bw: nothing remarkable was observed
Females:
- 16.0 ml/kg bw: in victims: lungs dark red; stomachs filled with hard mass; salivary glands with pus-filled nodule in one female; in survivors: lungs dark red; salivary glands enlarged
- 8.0 ml/kg bw: lungs mottled maroon and dark pink
- 4.0 ml/kg bw: in victims: lungs dark red; in survivors: lungs dark red; stomachs filled with hard mass
- 2.0ml/kg bw: nothing remarkable was observed - Other findings:
- The authors report that the test item reacted very quickly with water to form a hard mass. Since a hard mass in stomachs was noted at necropsy, which was assumed to be reacted sample material, the deaths were concluded to be most likely due to obstruction of the stomach and intestine.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was investigated for acute oral toxicity according to a protocol that is similar to the OECD TG 401, but without compliance with GLP. The test material was administered by stomach intubation to 5 Wistar rats each sex and dose group at doses of 2100, 4200, 8400, and 16 800 mg/kg bw. The LD50 was determined to be 4200-8400 mg/kg bw for males and 3780 mg/kg bw for females, respectively. The predominant clinical signs detected were sluggishness; unsteady gait; prostration; red, crusty discolouration on mouth and nose area; gaspping; salivation; and wheezing. Mean body weights were affected in high dose males and for females in all dose groups. Gross pathology revealed for animals found dead stomachs filled with hard mass; dark red lungs; or lungs with maroon pathy discolouration. One victim showed a dark red liver. Based on this data, classification for acute oral toxicity according to 67/584/EEC and EC/1272/2008 is not warranted.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 780 mg/kg bw
- Quality of whole database:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. However, no information is given on the test material purity.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- There are no reliable data for the inhalation route. However, there is one study with a reliability score of 4.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no data on test material purity is given; use of 4 animals per sex per dose level
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: trunk
- Type of wrap if used: impervious sheeting
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Constant volume used: no - Duration of exposure:
- 24 h
- Doses:
- Males:
- 8.0, 11.3, and 16.0 ml/kg bw as stated in the study report
- volumes applied correspond to doses of 8400, 11 865, and 16 640 mg/kg bw (converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4)
Females:
- 4.0, 8.0, and 16.0 ml/kg bw as stated in the study report
- volumes applied correspond to doses of 4200, 8400, and 16 800 mg/kg bw (converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4) - No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animal weights were recorded at day 0 (prior to dosing), and on days 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- LD50 was calculated by the moving average method and is based on a 14 days observation period.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 16 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 8.43 - 30.6
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 16 800 mg/kg bw
- 95% CL:
- 8 851.5 - 32 130
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.04 g/ml, see IUCLID Section 4.4
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 11.3 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 5.09 - 25.2
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 11 865 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 344.5 - 26 460
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.04 g/ml, see IUCLID Section 4.4
- Mortality:
- Males:
8 ml/kg bw: 0/4
11.3 ml/kg bw: 0/4
16 ml/kg bw: 2/4
Females:
4 ml/kg bw: 0/4
8 ml/kg bw: 1/4
16 ml/kg bw: 3/4 - Clinical signs:
- other: Males: 8 ml/kg bw: none noted 11.3 ml/kg bw: unsteady gait at day 1 16 ml/kg bw: prostration of 2 animals at day 1 Females: 4 ml/kg bw: none noted 8 ml/kg bw: none noted 16 ml/kg bw: prostration at day 1 No further details are given in the study report
- Gross pathology:
- Males:
8 ml/kg bw: tracheae red; lungs of 1 was deep maroon
11.3 ml/kg bw: lungs of 2 were deep maroon
16 ml/kg bw: in animals found dead discoloured lungs (red or salmon) were observed; in survivors tracheae with red patches were observed; 1 bladder was filled with dark yellow fluid.
Females:
4 ml/kg bw: tracheae of 2 red, lungs of 2 with deep maroon patches
8 ml/kg bw: lungs of 1 mottled with with tan caseous nodules; lungs of 1 deep maroon; heart of 1 with white film like appearance on pericardial sac (histopathology revealed bronchopneumonia, pleuritis, pericarditis)
16 ml/kg bw: tracheae of 3 with dark red patches throughout; lungs of 1 mottled; liver of 1 mottled; bladder of 1 with dark fluid - Other findings:
- - Local effects
Males:
8 ml/kg bw: edema, erythema, fissuring, desquamation
11.3 ml/kg bw: edema, erythema, fissuring, desquamation
16 ml/kg bw: edema, erythema, fissuring, desquamation
Females:
4 ml/kg bw: edema, erythema, fissuring, desquamation
8 ml/kg bw: edema, erythema, fissuring, desquamation, pus-filled nodules over dosed area
16 ml/kg bw: edema, erythema, fissuring, scabs - Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was tested for acute dermal toxicity according to a test protocol that is comparable to the OECD TG 402, but without GLP compliance. The test material was occlusively administered to 4 New Zealand White rabbits each sex and dose group for 24 h. The doses applied were 8400, 11 865 and 16 800 mg/kg bw for males and 4200, 8400, and 16 800 mg/kg bw for females, respectively. The LD50 was determined to be 16 800 mg/kg bw (males) and 11 865 (females) mg/kg bw. The predominant clinical signs detected were unsteady gait and prostration, as well as local effects, such as oedema, erythema and desquamation. Gross pathology revealed red tracheae; lungs deep maroon, lungs mottled with with tan caseous nodules, and heart with white film like appearance on pericardial sac (histopathology revealed bronchopneumonia, pleuritis, pericarditis). Based on this data, classification for acute dermal toxicity according to 67/584/EEC and EC/1272/2008 is not warranted.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 11 865 mg/kg bw
- Quality of whole database:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. However, no information is given on the test material purity.
Additional information
Acute toxicity: oral
In the available key study (Bushy Run Research Center, 1982a) the test item was investigated for acute oral toxicity according to a protocol that is similar to the OECD TG 401, but without compliance with GLP. The test material was administered by stomach intubation to 5 Wistar rats each sex and dose group at doses of 2100, 4200, 8400, and 16 800 mg/kg bw. The LD50 was determined to be 4200-8400 mg/kg bw for males and 3780 for females, respectively. The predominant clinical signs detected were sluggishness; unsteady gait; prostration; red, crusty discolouration on mouth and nose area; gasping; salivation; and wheezing. Mean body weights were affected in high dose males and for females in all dose groups. Gross pathology revealed for animals found dead stomachs filled with hard mass; dark red lungs; or lungs with maroon patchy discolouration. One animal found dead showed a dark red liver.
Acute toxicity: dermal
In the available key study (Bushy Run Research Center, 1982a) the test item was tested for acute dermal toxicity according to a test protocol that is comparable to the OECD TG 402, but without GLP compliance. The test material was occlusively administered to 4 New Zealand White rabbits each sex and dose group for 24 h. The doses applied were 8400, 11 865 and 16 800 mg/kg bw for males and 4200, 8400, and 16 800 mg/kg bw for females, respectively. The LD50 was determined to be 16 640 (males) and 11 752 (females) mg/kg bw. The predominant clinical signs detected were unsteady gait and prostration, as well as local effects, such as oedema, erythema and desquamation. Gross pathology revealed red tracheae; lungs deep maroon, lungs mottled with tan caseous nodules, and heart with white film like appearance on pericardial sac (histopathology revealed bronchopneumonia, pleuritis, pericarditis).
Acute toxicity: inhalation
No reliable data is available for acute toxicity via inhalation. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2 of REACH Annex VIII) does not need to be conducted as reliable data via the oral and dermal routes are available. Nevertheless, supporting data derived from a summary report is available (Bushy Run Research Center, 1982a). In this non-guideline study, which was not compliant to GLP, the test item was tested for acute inhalation toxicity. 5 Hilltop-Wistar albino rats each sex were exposed to substantially saturated vapour for 6 h. The vapour was produced by enclosing the test material in a sealed 120 l animal chamber for approximately 18 h (static concentration). Oxygen was added, as needed, to maintain a chamber oxygen content of approximately 20%. No deaths occurred throughout the study period. However, ataxia and slow righting reflex were observed after exposure. Gross pathology revealed no remarkable findings. The LC50 was found to be > vapour saturation at 23°C.
Justification for classification or non-classification
The available data are reliable and suitable for classification. Based on this data, classification for acute toxicity according to 67/584/EEC and EC/1272/2008 is not warranted.
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