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Diss Factsheets
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EC number: 429-630-8 | 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
From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.
From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.
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:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 % - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 – 10 weeks
- Weight at study initiation: 174 – 212 g
- Fasting period before study: ca. 17 h
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40 – 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- Application volume: 10 mL/kg bw
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 m / 3 f
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Examinations: clinical signs and body weight
Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality in both sexes.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- The body weight of the animals was within the range commonly recorded for animals of this strain and age.
- Gross pathology:
- No adverse effects were noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived.
- Executive summary:
From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 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:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 % - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 - 12 weeks
- Weight at study initiation: 200 - 234 g
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40 – 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- About 24 h before treatment the backs of the animals were clipped exposing an area of ca. 10 % of the total body surface. On test day 1 the test item was applied at a dose level of 2000 mg/kg bw evenly on the intact skin. The application volume was 2.16 mL/kg bw. 24 h after treatment the dressing was removed and the skin was flushed with water and dried with paper towels.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 m / 5 f
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Examinations: clinical signs and body weight
Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality in both sexes.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- The body weight of the animals was within the range commonly recorded for animals of this strain and age.
- Gross pathology:
- No adverse effects were noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived.
- Executive summary:
From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.
From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.
Therefore, there is no need to classify the test item according to CLP.
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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