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EC number: 406-600-2 | CAS number: 89392-03-0 DPX-E6758
- 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
In an acute oral toxicity study in rats according to EC method B.1, the LD50 was determined to be > 5000 mg/kg bw for males and females. The dermal toxicity study according to EC method B.2 on Wistar rats resulted in a LD50 of > 2000 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:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 196 - 209 g / females: 156 - 176 g
- Fasting period before study: overnight prior to dosing
- Housing: group housing of 5 animals per sex per cage in polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet (Kliba 343 from KlingentalmOhle AG, Kaiseraugst, Switzerland).
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 55%
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- prepared by reverse osmosis
- Details on oral exposure:
- The formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Homogeneity of the test substance in vehicle was obtained by stirring and shaking. The dose volume was 20 ml/kg body weight.
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration:
- mortality: at periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
- body weights: days 1, 8 and 15
- symptoms: at periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes - Preliminary study:
- not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 5000 mglkg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mglkg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No signs of toxicity were observed.
- Gross pathology:
- No treatment-related macroscopic findings were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity LD50 on rats was found to be > 5000 mg/kg.
- Executive summary:
The study was performed according to the standard method EU B.1 on Wistar rats with a single dose of 5000 mg/kg. Five animals were used per sex. The animals were treated orally by gavage with an aqueous suspension of the the test material. The LD50 was determined to be > 5000 mg/kg; therefore, the test item does not have any classification/labelling requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
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
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 203 - 228 g / females: 165 - 184 g
- Shaving: one day before exposure
- Housing: individual housing in polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet (Kliba 343 from KlingentalmOhle AG, Kaiseraugst, Switzerland).
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 55%
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial light - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
Area of exposure: formulation was applied to an area of approx. 25 cm2 (5x5 cm) for males and 18 cm2 (3.5x5 cm) for females by application on a gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, St. Paul, U.S.A.), with drops of petrolatum
TEST MATERIAL / VEHICLE
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Dose volume:10 ml/kg body weight.
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration:
- mortality: at periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
- body weights: days 1, 8 and 15
- symptoms: at periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes - Preliminary study:
- not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mglkg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mglkg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Neither clinical signs of toxicity nor local effects such as irritation of treated skin area were observed.
- Gross pathology:
- No treatment-related macroscopic findings were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal toxicity LD50 on rats was found to be > 2000 mg/kg.
- Executive summary:
The study was performed according to the standard method EU B.2 on Wistar rats with a single dose of 2000 mg/kg. Five animals were used per sex. The animals were treated dermally by semi-occlusive application of an aqueous suspension of the the test material. The LD50 was determined to be > 2000 mg/kg; therefore, the test item does not have any classification/labelling requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Guideline study; GLP; Klimisch 1
Justification for selection of acute toxicity – dermal endpoint
Guideline study; GLP; Klimisch 1
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).
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