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EC number: 428-710-1 | CAS number: 207574-76-3
- 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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- 5 male and 5 female rats in one step with two doses
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- SPF-Wistar rats, strain Winkelmann, Paderborn
- Mean body weight male: 210 - 230 g
- Mean body weight female: 190 - 210 g
- Fasting period before study: 16 hours
- Housing: animals were kept in groups of 5 male and 5 female "at random" divided in single cages
- Diet: laboratory standard diet (Altromin, Lage), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22.5 ± 2.5 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Administration by oral gavage, using a non-flexible stomach tube, as 10% suspension in 1% CMC.
VEHICLE
- Concentration in vehicle: 10 %
MAXIMUM DOSE VOLUME APPLIED:
- Dosage level 2000 mg/kg bw: 2.0 ml/100 g bw
- Dosage level 5000 mg/kg bw: 5.0 ml/100 g bw - Doses:
- 2000 and 5000 mg/kg bodyweight
- No. of animals per sex per dose:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- Not applicable. No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- During the study, no mortality could be observed.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the study.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- other: not classified according to Regulation (EC) 1272/2008.
- Conclusions:
- The oral LD50 value of the test item in Wistar rats was established to exceed 5000 mg/kg body weight. Based on these results and according to the EC criteria for classification and labelling according to CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement for oral toxicity.
- Executive summary:
The test item did not show any mortality in rats up to 5000 mg/kg bodyweight and is therefore considered practically non-toxic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- 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: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 9 weeks for males and 12 weeks for femals
- Weight at study initiation: males 224.3 - 238.5 g, females 197.1 - 217.9 g
- Housing: Groups of 5 in Makrolon type-4 cages with standard softwood bedding, during treatment and observation individually in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433 rat maintencance diet, available ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12, recorded music was played for approx. 8 hours during the light period - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approx. 10% of total body surface
- Type of wrap if used: semi occlusive dressing, wrapped around the abdomen and fixed with an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6.0 ml / kg bw
- Concentration (if solution): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Male: Number of animals: 5
Female: Number of animals: 5 - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality/Viability: Four times during test day 1 (day of administration) and once daily during days 2 to 15
- Body weights: on test day 1 (pre-administration), days 8 and 15
- Clinical sign: Each animal was examined for changes in appearance and behaviour four times during day 1 (day of administration), and once daily during days 2 to 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- Not applicable. No statistical analysis was used as no deaths occured
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occured during the study
- Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period
- Gross pathology:
- No macroscopic findings were observed at necropsy
- Interpretation of results:
- other: not classified according to Regulation (EC) 1272/2008.
- Conclusions:
- As no mortality occured in the acute dermal toxicity test (OECD 402), the LD50 of the test item is > 2000 mg/kg bodyweight. Based on these results and according to the EC criteria for classification and labelling according to GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement for dermal toxicity.
- Executive summary:
As no mortality occured in the acute dermal toxicity test (OECD 402), the LD50 of the test item is > 2000 mg/kg boddyweight and therefore the substance is not classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
Since no classification criteria according to CLP (Regulation (EC) No. 1272/2008) are fulfilled, the substance is not classified for acute toxicity, neither by the oral nor by the dermal route.
Non-classification by the inhalation route is adequate since no expsoure via the inhalation route is to be expected.
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