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EC number: 260-280-7 | CAS number: 56602-77-8
- 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
- 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
LD50 1000 -1400 mg/kg bw (males); LD50 961 mg/kg bw (females) (rat), OECD 401, Chida, T. (1992).
Inhalation
Data requirement waived - substance is corrosive to skin.
Dermal
Data requirement waived - substance is corrosive to skin.
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:
- 9 July 1991 - 12 August 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- .
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Toxicity Studies of Drugs (Notification No. 2. of the First Evaluation and Registration Division, 1989
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc.
- Age at study initiation: 5 weeks
- Weight at study initiation: 121 - 135g for males, 96 - 111g for females
- Fasting period before study: Yes (overnight before dosing and for ca. 3 hours after dosing)
- Housing: polycarbonate cage with bedding for experimantal animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 40-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% CMC-Na solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 mg/mL to 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 500 mg/kg (5 males)
700 mg/kg (5 males)
1000 mg/kg (5 males)
1400 mg/kg (5 males)
2000 mg/kg (5 males)
700 mg/kg (5 females)
1000 mg/kg (5 females)
1400 mg/kg (5 females)
2000 mg/kg (5 females) - 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: at 30 min, 1, 3, 6 and 8 hours after dosing and afterwards, once daily for 14 days. The body weights were measured just before dosing and on Days 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macropathology. - Statistics:
- 95 % of confidence limit for LD50 was calculated
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 1 400 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 961 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 883 - < 1 046
- Mortality:
- Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 700 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1400 mg/kg bw; Number of animals: 5; Number of deaths: 5
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 700 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 1400 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5 - Clinical signs:
- other: A decrease in locomotor activity was observed in 1 male in the 1000 mg/kg group from 1 hour after dosing; however, it recovered for once. After that; however, decreases in locomotor activity and/or tiptoe gait were observed from Day 2. Emaciation was obse
- Gross pathology:
- Abnormal contents like tar in the stomach and/or small intestine, hemorrhage of the glandular stomach and/or small intestine were frequently noted among the dead animals. Congestion of the adrenal, dark reddish change of the lung, dilatation of the urinary bladder, and slight bloody ascites were observed sporadically in some dead animals.
- Interpretation of results:
- harmful
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of test material was demonstrated to be between 1000 and 1400 mg/kg bw in males and 961 mg/kg bw in females (883 - 1046 mg/kg bw, 95% of confidence limit).
- Executive summary:
The acute toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the Guidelines for Toxicity Studies of Drugs (Notification No. 2. of the First Evaluation and Registration Division, 1989.
During the study the test material was administered once orally to male and female SD rats, and its acute toxicity was assessed. In addition, its lethal dose was calculated.
The dose levels were set at 500, 700, 1000, 1400, and 2000 mg/kg for 5 males/group, and 700, 1000, 1400, and 2000 mg/kg for 5 females/group. The dosing volume was set at 10 mL/kg.
All animals in the 1400 mg/kg or higher groups died by Day 2. Three females in the 1000 mg/kg group died on the day after dosing. From the mortality, LD50 values were between 1000 and 1400 mg/kg in males and 961 mg/kg in females (883 - 1046 mg/kg, 95% of confidence limit).
In clinical observation, decreases in locomotor activity, crouching position, lateral position, cyanosis, and/or ataxic gait were observed in both sexes. Moreover, gasping, tiptoe gait, anemia, emaciation, and/or loose stool were observed in males.
Although decreases in body weight were observed in 1 male in the 1000 mg/kg group until 7 days after dosing, it recovered thereafter. The body weights of the other animals were increased constantly during the observation period.
Necropsy findings of dead animals were as follows: abnormal contents like tar in the stomach and/or small intestine, hemorrhage of the glandular stomach and/or small intestine, congestion of the adrenal, dark reddish change of the lung, dilatation of the urinary bladder, and bloody ascites. In necropsy at the end of recovery period, no abnormalities were observed.
Under the conditions of the study the acute median lethal oral dose (LD50) of the test material to rats was demonstrated to be between 1000 and 1400 mg/kg bw in males and 961 mg/kg bw in females (883 - 1046 mg/kg bw, 95% of confidence limit).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 961 mg/kg bw
- Quality of whole database:
- The key study was performed in accordance with standardised guidelines and under GLP conditions and was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). The quality of the database is therefore considered to be good.
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
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Column 2 of REACH Annex VIII, information requirement 8.5, this study does not need to be conducted because the substance is classified as skin corrosion.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Column 2 of REACH Annex VIII, information requirement 8.5, this study does not need to be conducted because the substance is classified as skin corrosion.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
The acute toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the Guidelines for Toxicity Studies of Drugs (Notification No. 2. of the First Evaluation and Registration Division, 1989).
During the study the test material was administered once orally to male and female SD rats, and its acute toxicity was assessed. In addition, its lethal dose was calculated.
The dose levels were set at 500, 700, 1000, 1400, and 2000 mg/kg for 5 males/group, and 700, 1000, 1400, and 2000 mg/kg for 5 females/group. The dosing volume was set at 10 mL/kg.
All animals in the 1400 mg/kg or higher groups died by Day 2. Three females in the 1000 mg/kg group died on the day after dosing. From the mortality, LD50 values were between 1000 and 1400 mg/kg in males and 961 mgkg in females (883 - 1046 mg/kg, 95 % of confidence limit).
In clinical observation, decreases in locomotor activity, crouching position, lateral position, cyanosis, and/or ataxic gait were observed in both sexes. Moreover, gasping, tiptoe gait, anemia, emaciation, and/or loose stool were observed in males.
Although decreases in body weight were observed in 1 male in the 1000 mg/kg group until 7 days after dosing, it recovered thereafter. The body weights of the other animals were increased constantly during the observation period.
Necropsy findings of dead animals were as follows: abnormal contents like tar in the stomach and/or small intestine, hemorrhage of the glandular stomach and/or small intestine, congestion of the adrenal, dark reddish change of the lung, dilatation of the urinary bladder, and bloody ascites. In necropsy at the end of recovery period, no abnormalities were observed.
Under the conditions of the study the acute median lethal oral dose (LD50) of the test material to rats was demonstrated to be between 1000 and 1400 mg/kg bw in males and 961 mg/kg bw in females (883 - 1046 mg/kg bw, 95 % of confidence limit).
Inhalation
In accordance with Column 2 of REACH Annex VIII, information requirement 8.5, this study does not need to be conducted because the substance is classified for skin corrosion.
Dermal
In accordance with Column 2 of REACH Annex VIII, information requirement 8.5, this study does not need to be conducted because the substance is classified for skin corrosion.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance meets the criteria for classification as Acute Category 4 with the hazard statement H302: Harmful if swallowed.
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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