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EC number: 264-261-4 | CAS number: 63469-23-8
- 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
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- 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
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- Nanomaterial pour density
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Specific investigations
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Acute toxicity - oral: A K2 key study is available (Auletta, 1979a): based on this study, the oral LD50 for male/female rats was estimated to be 2200 mg/kg body weight. The test was performed according to a method equivalent to OECD Guideline 401.
In addition, a K3 supporting study is available (van Huygevoort, 2002): based on this study, the oral LD50 for female rats was considered to exceed 2000 mg/kg body weight.
Acute toxicity - inhalation: In accordance with the specific rules for adaptation from column 1 (REACH Annex VII and VIII), no acute toxicity study needs to be conducted as the substance is classified as corrosive to the skin. Moreover, reliable data via two other routes of administration is available.
Acute toxicity - dermal: For the dermal route, a K2 key study is available (Auletta, 1979b): based on this study, the dermal LD50 for male/female rabbits was estimated to be 3300 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:
- 1979-03-14 to 1979-04-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non GLP study performed according to a method equivalent to OECD Guideline 401. Limited information was reported on test conditions, however sufficient animals were tested.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4236-21-35
- Substance type: Clear colourless liquid - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Mass.
- Age at study initiation:
- Weight at study initiation: 220 to 314 grams
- Fasting period before study: approximately seventeen hours prior to administration of test material
- Housing: Following dosing, the rats were individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
No data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was administered by oral intubation in the form received. The dose levels were calculated according to the density provided by the sponsor as being 0.944 g/mL.
- Doses:
- The animals were dosed at the following dose levels: 1000, 1400, 2000, 2800 and 4000 mg/kg.
- 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: Bodyweights were recorded prior to fasting, at day 7 and at the termination of the study (day 14)
- Necropsy of survivors performed: yes: A gross necropsy was performed on all animals at the time of death or terminal sacrifice (day 14).
- Observations for mortality and overt signs of effect were made at 0-2 hours and at 4-6 hours following dosing and daily thereafter for fourteen days. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 200 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 900 - <= 2 500
- Mortality:
- 1000 mg/kg: 1/10 animals died
1400 mg/kg: 0/10 animals died
2000 mg/kg: 2/10 animals died
2800 mg/kg: 9/10 animals died
4000 mg/kg: 10/10 animals died - Clinical signs:
- other: other: other:
- Body weight:
- other body weight observations
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 for this substance is 2200 mg/kg with 95% confidence limits of 1900 to 2500 mg/kg. Based on this result, the test substance is not to be classified according to the CLP Regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 200 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:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
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:
- 1979-03-28 to 1979-05-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non GLP study performed according to a method equivalent to OECD Guideline 402. Only 2 animals per sex and per dose tested instead of 5 as recommended in the OECD Guideline 402.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only 2 animals per sex and per dose tested instead of 5 as recommended in the OECD Guideline 402
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4236-21-35
- Substance type: Clear colorless liquid
- Physical state: Liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Marland Breeding Farms, Inc., Hewitt, N.J.
- Age at study initiation: unknown
- Weight at study initiation: 2.5 to 3.1 kg - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
The hair of each rabbit was clipped from the trunk so as to expose at least 10% of the body surface area. The skin of half of the animals (4 males, 4 females) was abraded longitudinally every 2 or 3 centimeters so as to penetrate the stratum corneum but not so deep as to disturb the derma or produce bleeding.
REMOVAL OF TEST SUBSTANCE
Following 24 hours of exposure, the sleeves were removed and observations were made for edema, erythema and eschar formation. The exposed area was then wiped free of excess test material.
TEST MATERIAL
The test material was administered as received. The dose levels were calculated based on the density of the test material which was provided by the sponsor as being 0.944 g/mL.
The test material was held in contact with the skin by an 8-ply gauze wrapping and a sleeve made of impervious plastic sheeting designed to contain the dose without leakage or undue pressure. Collars designed to prevent the ingestion of the test material were worn by all animals throughout the study. - Duration of exposure:
- 24 hours
- Doses:
- 2000, 2800, 4000 and 5600 mg/kg
The dose levels were calculated based on the density of the test material which was provided by the sponsor as being 0.944 g/mL. - No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded initially, on day 7 and at the termination of the study (day 14)
- Necropsy of survivors performed: yes: A gross necropsy was performed on spontaneous deaths.
- Observations for mortality and overt signs of effect were made at 0-2 and 4-6 hours following dosing, and daily thereafter for fourteen days. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 200 - 4 400
- Mortality:
- at 2000 mg/kg: 0/4 animals died
at 2800 mg/kg: 2/4 animals died
at 4000 mg/kg: 2/4 animals died
at 5600 mg/kg: 4/4 animals died - Clinical signs:
- other: other: other:
- Body weight:
- other body weight observations
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the substance was estimated to be 3300 mg/kg with 95% confidence limits of 2200 to 4400 mg/kg. The substance is not to be classified according to the CLP Regulation
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 300 mg/kg bw
Additional information
Acute toxicity: oral
Auletta (1979a) investigated the acute oral toxicity of 1000, 1400, 2000, 2800 and 4000 mg/kg in 5 male/female Sprague-Dawley albino rats. After 14 days of observation following mortalities were observed: at 1000 mg/kg 1/10 animals died, 1400 mg/kg 0/10 animals died, 2000 mg/kg 2/10 animals died, 2800 mg/kg 9/10 animals died, 4000 mg/kg 10/10 animals died. Piloerection was noted at all levels throughout the observation period in the majority of the surviving animals. Motor activity decrease was evident at all levels most notably within twenty-four hours following test material administration. Also noted within the twenty-four-hour period following intubation were red nasal and oral discharges and respiratory rate decrease. These signs were evident mainly at the 1000, 1400 and 2000 mg/kg dose levels.
All surviving animals at all dose levels exhibited weight gains during the fourteen-day post-dose observation period. This study was selected as key study. In addition, a K3 supporting acute oral toxicity study was conducted in rats and the acute oral LD50 observed in this study was observed to be > 2000 mg/kg (van Huygevoort, 2002).
Acute toxicity: dermal
For the dermal route, a K2 key study is available (Auletta, 1979b). New Zealand White rabbits were exposed to 2000, 2800, 4000 and 5600 mg/kg of the substance. After 14 days of observation following mortalities were observed: at 2000 mg/kg: 0/4 animals died; at 2800 mg/kg: 2/4 animals died; at 4000 mg/kg: 2/4 animals died; at 5600 mg/kg: 4/4 animals died. At the twenty-four-hour dermal observation the majority of the animals at all levels exhibited severe erythema accompanied by necrotic skin and moderate edema. Physical signs noted in the majority of animals at all dose levels during the fourteen-day post-dose observation period were clear nasal discharge, piloerection and motor activity decrease. During the two-week observation period the majority of the surviving animals showed no change in weight or a slight weight gain. Based on this study, the dermal LD50 for male/female rabbits was estimated to be 3300 mg/kg.
Acute toxicity: inhalation
No acute inhalation toxicity study was performed.
Justification for classification or non-classification
Based on one K2 study (Auletta, 1979a), the oral LD50 for male/female rats was estimated to be 2200 mg/kg body weight. According to the criteria of the CLP Regulation, the substance does not have to be classified for acute oral toxicity as the LD50 value is > 2000 mg/kg bw.
Based on one K2 study (Auletta, 1979b), the dermal LD50 for male/female rabbits was estimated to be 3300 mg/kg body weight. According to the criteria of the CLP Regulation, the substance does not have to be classified for acute dermal toxicity as the LD50 value is > 2000 mg/kg bw.
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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