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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- 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, UK
- Age at study initiation: eight to twelve weeks.
- Weight at study initiation: males: 205 - 218 g, females: 200 - 221 g,
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: Rat and Mouse Expanded Diet No . 1, Special Diet Services Limited, Witham, Essex, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 51 - 65
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: The test material was moistened with distilled water.
- Details on dermal exposure:
- TEST SITE
- On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary dippers.
- Area of exposure: back and flanks
- % coverage: approximating to 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semioccluded with a piece of self-adhesive bandage. The animals were caged individually for the 24-hour exposure period. Shortly after dosing the dressings were examined to ensure that they were securely in place.
REMOVAL OF TEST SUBSTANCE
- Washing: the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with
distilled water to remove any residual test material.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg / kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: once daily
- Frequency of weighing: prior to application of the test material on day 0 and on day 7 and 14.
- Necropsy of survivors performed: yes, 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. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: clinical signs, body weight, test sites were examined for evidence of primary irritation and scored according to Draize J.H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy 01 Sciences, Washington DC p. 31.
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. Orange-coloured staining caused by the test material was noted at the treated skin sites of all animals and prevented an evaluation of the degree of erythema on Day 1. No signs of skin irritation
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Signs of toxicity (local):
On day 1, scoring for erythema due to orange staining was not possible. No signs of dermal irritation were detected until the end of the study.
Any other information on results incl. tables
Table 1: Mean body weight |
|||
|
|
Mean |
SD* |
Day 0 |
Males |
213.4 |
5.22 |
|
Females |
208.6 |
8.62 |
Day 7 |
Males |
256.6 |
18.37 |
|
Females |
221.6 |
9.29 |
Day 14 |
Males |
311.4 |
23.16 |
|
Females |
238 |
11.98 |
Table 2: Body weight gain (g) during week 1 and 2 |
|||
|
|
Mean |
SD* |
Week 1 |
Males |
43.2 |
15.91 |
|
Females |
13.0 |
3.61 |
Week 2 |
Males |
54.8 |
14.81 |
|
Females |
16.4 |
3.51 |
* standard deviation
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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