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Diss Factsheets
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EC number: 428-880-5 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): DS-2920A-E
- Physical state: orange solid
- Analytical purity: no data
- Lot/batch No.: 004
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley (Crl : CD ® (SD) IGS BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd ., Margate, Kent, U.K.
- Age at study initiation: eight to twelve weeks.
- Weight at study initiation: males: 201 - 217g, females: 200 - 214g,
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: up to five by sex in solid floor polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded Diet No . 1, Special Diet Services Limited, Witham, Essex, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 54 - 67
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg / ml
- Amount of vehicle (if gavage): The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
- Justification for choice of vehicle: No data
DOSE VOLUME APPLIED: 10 ml / kg
DOSAGE PREPARATION (if unusual):
- For the purpose of the study the test material was freshly prepared, as required, as a solution at the appropriate concentration in distilled water.
- The concentration, homogeneity and stability of the test material preparations were not determined by analysis.
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- • Range-finding Study:
2000 mg / kg bodyweight were administered at a concentration of about 200 mg / mL at a dose volume of 10 mL / kg to one male and one female rat, respectively.
- Duration of observation period following administration: five days.
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1 2, and 4 hours after dosing and subsequently once daily for five days. Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes.
- Necropsy of survivors performed: no
There were no deaths or clinical signs of toxicity.
• Main Study:
Based on the information of the range-finding study, a dose level of 2000 mg / kg bodyweight was selected for the main study.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes, at the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality. No signs of systemic toxicity.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study. The faeces of all animals was stained orange one and two days after treatment. The urine of all females was also stained orange during this period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No other findings.
Any other information on results incl. tables
Table 1: Mean body weight |
|||
|
|
Mean |
SD |
Day 0 |
Males |
208.6 |
5.86 |
|
Females |
206.0 |
5.83 |
Day 7 |
Males |
269.2 |
9.68 |
|
Females |
238.0 |
8.80 |
Day 14 |
Males |
315.4 |
17.52 |
|
Females |
257.2 |
11.82 |
Table 2: Body weight gain (g) during week |
|||
|
|
Mean |
SD |
Week 1 |
Males |
60.6 |
8.11 |
|
Females |
32.0 |
3.94 |
Week 2 |
Males |
46.2 |
8.93 |
|
Females |
19.2 |
3.90 |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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