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EC number: 701-394-3 | CAS number: 1782069-81-1
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
In standard single-dose toxicity studies in rats the following results were obtained:
In an OECD401 study, the acute oral LD50 in rats was determined to be > 2000 mg/kg bodyweight.
In an OECD402 comparable study, the acute dermal LD50 in rats was determined to be >10000 mg/kg bodyweight
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:
- 29 March 1989 to 13 April 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Fü-albino SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Males about 6 weeks, females 6 to 7 weeks.
- Weight at study initiation: Males 125.0 to 132.7 g, females 125.0 to 140.6 g.
- Fasting period before study: About 18 hours.
- Housing: Individually caged.
- Diet: NAFAG standard rat maintenance diet, ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 45 to 65 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours darkness. - Route of administration:
- oral: gavage
- Vehicle:
- other: Standard Suspending Vehicle (SSV)
- Remarks:
- 1000 mL SSV contains 5 g sodium carboxy methyl cellulose (medium viscosity), 4 mL Tween 80, 5 mL benzylalcohol pro analysi, 9 g sodium-chloride pro analysi and distilled water.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage):
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weigth
DOSAGE PREPARATION: The test article was kept suspended in Standard Suspending Vehicle (SSV) using a homogeniser. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 16 days
- Frequency of observations and weighing: Mortality was recorded continuously and body weight was recorded on days 0 (immediately before treatment), 2, 6, 9, 13 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Behaviour, vivacity, signs of injury, signs of sickness and abnormality were performed repeatedly on the treatment day and daily during the treatment-free observation period. - 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:
- No deaths occurred.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No autopsy findings were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 in rats was determined to be > 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test item was determined in a 16 -day limit test conducted according to OECD 401. Male and female Fü-albino SPF rats, 6 to 7 weeks old, were dosed with the test item at a nominal concentration 2000 mg/kg bodyweight in Standard Suspending Vehicle by oral gavage. The dose volume was 10 mL/kg. Rats were observed for mortality and clinical signs and body weight. The LD50 was determined to be > 2000 mg/kg bw. There were no effects in body weight development and no clinical signs or autopsy findings were recorded. This study is considered reliable without restriction (Klimisch 1).
Reference
Table 1. Body weights
Sex | Mean body weights in g (standard deviation) | |||||
n = 5 | Day 0 | Day 2 | Day 6 | Day 9 | Day 13 | Day 15 |
Male | 129.2 (2.8) | 157.9 (4.2) | 187.8 (6.2) | 206.4 (8.1) | 225.4 (9.2) | 210.0 (9.1) |
Female | 130.2 (6.2) | 147.5 (7.3) | 159.2 (9.8) | 165.8 (8.0) | 174.4 (8.9) | 164.0 (9.8) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One key study is available (Klimisch 1).
Acute toxicity: via inhalation route
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- - Principle of test: Male and female rats were exposed to the test item in peanut oil DAB 7 (1:1). The treatment was applied to shaved skin and kept under occlusion for 24 hours. The treated area was then washed with water and rats were observed for 14 days.
- Short description of test conditions: Experimental conditions were maintained at 23 to 33 °C with 45 to 75 % relative humidity. Five male and five females rats were used per treatment and control. Animals were individually caged and provided with food and water ad libitum.
- Parameters analysed / observed: Mortality, intoxication symptoms, local changes, body weight - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar-AF/HAN-EMD-SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 125 to 143 g (mean 137 g)
- Housing: Individually caged in wire cages Type III.
- Diet (e.g. ad libitum): Altromin R, ad libitum.
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 33 °C
- Humidity (%): 45 to 75 % - Type of coverage:
- occlusive
- Vehicle:
- peanut oil
- Remarks:
- DAB 7
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: The treated skin area was covered with tin foil, which was fixed and sealed with the aid of a rubber sleeve.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, substance residues were washed off with water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 10 mL/kg body weight
- Concentration: 50%
- Constant volume or concentration used: Constant concentration used.
VEHICLE
- Amount(s) applied: 10 mL/kg bodyweight
- Concentration: 50% - Duration of exposure:
- 24 hours
- Doses:
- 10 g/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed and weighed daily, Monday through Friday.
- Other examinations performed: Evaluation of the changes occurring in the application area was made according to Draize. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortalities were recorded.
- Clinical signs:
- other: There were no signs of absorptive intoxication and no symptoms of irritation were observed.
- Gross pathology:
- No pathoanatomical abnormalities were observed.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The dermal LD50 in rats was determined to be > 10000 mg/kg bodyweight.
- Executive summary:
The acute dermal toxicity of the test item was determined in a 14 -day limit test. A nominal concentration of 10 g/kg bodyweight test item in peanut oil DAB 7 (1:1) was applied to a 6 x 6 cm area of shaved skin of male and female Wistar-AF/HAN-EMD-SPF rats. A vehicle control was included in the study. The treated area was occluded for 24 hours, after which substance residues were washed off with water. Rats were observed for mortality, intoxication, local changes and body weight. The LD50 was determined to be > 10 g/kg bw. There were no signs of absorptive intoxication, symptoms of irritation or pathoanatomical abnormalities. All rats lost weight in the first two days after application, however weight gain was continuous thereafter. This study is considered reliable with restriction (Klimisch 2) as the test was conducted similar to OECD Guideline 402, with minor limitations in reporting.
Reference
Table 1. Body weights
Dose (mg/kg) | Sex | Mean body weight (g) | Difference of final weight from starting weight (g) | |||||
0 days | 1 day | 3 days | 7 days | 10 days | 14 days | |||
Vehicle | Male | 139 | 123 | 132 | 154 | 168 | 187 | +48 |
Vehicle | Female | 142 | 126 | 139 | 148 | 157 | 166 | +24 |
10000 | Male | 133 | 117 | 129 | 152 | 165 | 186 | +53 |
10000 | Female | 141 | 126 | 136 | 145 | 153 | 161 | +20 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- One study is available (Klimisch 2) for weight of evidence.
Additional information
The acute oral toxicity of the test item was determined in a limit test conducted according to OECD 401 (1989). Male and female Fü-albino SPF rats, 6 to 7 weeks old, were dosed with the test item at a nominal concentration 2000 mg/kg bodyweight in Standard Suspending Vehicle by oral gavage. The dose volume was 10 mL/kg. Rats were observed for mortality and clinical signs and body weight. The LD50 was determined to be > 2000 mg/kg bw. There were no effects in body weight development and no clinical signs or autopsy findings were recorded. This study is considered reliable without restriction (Klimisch 1).
The acute dermal toxicity of the test item was determined in a 14 -day limit test. A nominal concentration of 10 g/kg bodyweight test item in peanut oil DAB 7 (1:1) was applied to a 6 x 6 cm area of shaved skin of male and female Wistar-AF/HAN-EMD-SPF rats. A vehicle control was included in the study. The treated area was occluded for 24 hours, after which substance residues were washed off with water. Rats were observed for mortality, intoxication, local changes and body weight. The LD50 was determined to be > 10 g/kg bw. There were no signs of absorptive intoxication, symptoms of irritation or pathoanatomical abnormalities. All rats lost weight in the first two days after application, however weight gain was continuous thereafter. This study is considered reliable with restriction (Klimisch 2) as the test was conducted similar to OECD Guideline 402, with minor limitations in reporting.
Justification for classification or non-classification
One key study is available for the acute oral toxicity endpoint and one key studies is available for acute dermal toxicity. All studies were considered to be of robust design and well reported and assigned a Klimisch score of 1 or 2. As the acute oral and dermal studies resulted in predicted LD50 levels in excess of the 2000 mg/kg limit dose, it was concluded that the test item is not classified for acute toxicity according to the CLP Regulation (EC) No 1272/2008.
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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