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EC number: 700-972-2 | CAS number: -
- 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
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Principles of method if other than guideline:
- Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw of the test substance by stomach intubation. The animals were observed for 14 d.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 150-250 g
- Fasting period before study: 24 h
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow (ad libitum)
- Water (e.g. ad libitum): ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Six adult SD rats per dose group were given the test substance by stomach intubation.
- Doses:
- 0, 5000, 10000 and 20000 mg/kg.
- No. of animals per sex per dose:
- Males: 6/dose/group
- Control animals:
- not specified
- Details on study design:
- Male SD rats were fasted for 24 h and then administered single doses of the test substance by stomach intubation followed by 14 d of observation period.
- Statistics:
- No data
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Number of dead/number dosed:
- No mortality occured at lowest dose of 5000 mg/kg, i.e., 0/6
- 50% mortality was observed In the mid dose group of 10000 mg/kg, i.e., 3/6
- Almost all animals died in the highest dose group of 20000 mg/kg, i.e., 5/6. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance, C18-unsatd. DEA, in Sprague Dawley rats. Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw by stomach intubation and observed for 14 d. Approximately 50% mortality occurred at the mid dose. Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw (Casey, 1976).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Principles of method if other than guideline:
- Groups of 20 fasted animals (10 males and 10 females) were exposed via oral gavage to 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: W. Gassner, Sulzfeld, Germany
- Weight at study initiation: males: 95 - 115 g; females: 90 - 110 g
- Fasting period before study: ca. 16 h
- Temperature: 22 +/- 1°C
- Housing: 5 animals/cage
- Lighting cycle (light:dark): 12:12
- Feed: Ssniff (pellets)
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 d
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination - Statistics:
- LD50 was calculated according to Kärber (Toxikologie für Veterinärmediziner, H.J. Hapke, 1975) and Weil (Biometrics 8, 249; 1952).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 14.21 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Equivalent to 14210 mg/kg bw; assuming the density to be approx. 1 g/cm3
- Remarks:
- (according to Kärber)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 13.82 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Equivalent to 13820 mg/kg bw; assuming the density to be approx. 1 g/cm3
- Remarks:
- (according to Weil)
- Mortality:
- 0% at 0 and 10.0 ml/kg bw
40% at 12.6 mL/kg bw
70% at 16.0 mL/kg bw
100% at 20.0 mL/kg bw - Clinical signs:
- other: Rough fur, pale extremities, diarrhea, increased lacrimation and slight to middle-strong lethargy and ataxia.
- Gross pathology:
- ANIMALS DYING DURING THE STUDY:
- Light to medium hyperemia and hemorragic edema in the lung.
- Light to medium hyperemia of the liver
- Light to medium hyperemia of the mucous membrane of the glands and the cutaneous mucous membrane of the stoimach
- Light to medium hyperemia of the mucous membrane of the duodenum
ANIMALS SACRIFICED AT THE END OF THE STUDY:
- Medium hyperemia and light hemorragic edema of the lungs
- Light to medium hyperemia of the liver
- Local thickeniung of the cutaneous mucous membrane of the stomach - Other findings:
- None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the LD50 of the test substance was found to be equivalent to 14.21 mL/kg bw (according to Kärber) or 13.82 ml/kg bw (according to Weil). These LD50 values are equivalent to 14210 and 13820 mg/kg bw, assuming a density of approximately 1 g/cm3.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test substance, C18-unsatd. DEA (purity not specified), in Sprague Dawley rats. Groups of 20 fasted animals (10 males and 10 females) were exposed via oral gavage to 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination. Mortality occured at 12.6 mL/kg bw. Signs of toxicity included rough fur, pale extremities, diarrhea, increased lacrimation and slight to middle-strong lethargy and ataxia. Animals dying during the study showed slight to medium effects in the lung, liver, glands, stomach and duodenum. In animals sacrificed at the end of the study, light to medium effects were observed in the lungs, liver and stomach. Under the study conditions, the LD50 of the test substance was found to be equivalent to 14.21 mL/kg bw (according to Kärber) or 13.82 ml/kg bw (according to Weil). These LD50 values are equivalent to 14210 and 13820 mg/kg bw, assuming a density of approximately 1 g/cm3 (Sandhowe-Grote, 1979).
Referenceopen allclose all
None.
None.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 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:
- other:
- Clinical signs:
- other: other:
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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Refer to the section 13 for details on the category justification.
- Qualifier:
- according to guideline
- Guideline:
- other: A modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 1.9-2.7 kg
No further information avaialble. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the 24 h exposure period the sleeve was removed and the skin sites gently cleansed.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Details on study design:
- All animals were observed daily thereafter for 14 d for mortality, skin response and general behavior.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalities observed.
- Clinical signs:
- other: All animals appeared normal through Day 14.
- Gross pathology:
- Not evaluated.
- Other findings:
- Not evaluated.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute dermal LD50 in rabbits was found to be >2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute dermal toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976).
Reference
None.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral
A study was conducted to determine the acute oral toxicity of the test substance, C18-unsatd. DEA, in Sprague Dawley rats. Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw by stomach intubation and observed for 14 d. Approximately 50% mortality occurred at the mid dose. Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw (Casey, 1976).
A study was performed to assess the acute oral toxicity of the test substance, C18-unsatd. DEA, in Sprague Dawley rats. Groups of 20 fasted animals (10 males and 10 females) were exposed via oral gavage to 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw. The animals were observed for 14 d, then sacrificed and subjected to gross pathological examination. Mortality occured at 12.6 mL/kg bw. Signs of toxicity included rough fur, pale extremities, diarrhea, increased lacrimation and slight to middle-strong lethargy and ataxia. Animals dying during the study showed slight to medium effects in the lung, liver, glands, stomach and duodenum. In animals sacrificed at the end of the study, light to medium effects were observed in the lungs, liver and stomach. Under the study conditions, the LD50 of the test substance was found to be equivalent to 14.21 mL/kg bw (according to Kärber) or 13.82 mL/kg bw (according to Weil). These LD50 values are equivalent to 14210 and 13820 mg/kg bw, assuming a density of approximately 1 g/cm3 (Sandhowe-Grote, 1979).
Dermal
A study was conducted to determine the acute dermal toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976).
Justification for classification or non-classification
The available data indicates that C18-unsatd. DEA has a low potential for acute toxicity (oral and dermal LD50 >10000 and >2000 mg/kg bw, respectively). The substance therefore does not meet the requirement for classification according to CLP (EC 1272/2008) criteria.
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