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Diss Factsheets
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EC number: 447-060-8 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 September 2002 to 10 October 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report):DV6850
- Substance type: powder
- Physical state: solid
- Analytical purity: 83.7%
- Lot/batch No.: R0332-52C
- Expiration date of the lot/batch: 2003/09/30
- Storage condition of test material: ca 4°C in the dark in dry conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK. Ltd., Bicester, Oxon, England
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 85-108g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately four hours after dosing
- Housing: In groups of three rats of the same sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): drinking water at libitum
- Acclimation period: minimum period of five days prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): relative humidity 40 - 70%.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): controlled by means of a time switch to provide 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg body weight
- Justification for choice of vehicle: soluble in water
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to the guideline, start with 2000mg/kg if no of low toxicity is expected - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations twice daily, Weighing on day 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: mortality clinical signs, body weight, macroscopic examination
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single oral gavage dose of DV6850 to a group of six rats (three males and three females) at a dose level of 2000 mg/kg bodyweight.
- Clinical signs:
- other: No clinical signs of reaction to treatment were observed in any animal throughout the duration of the study.
- Gross pathology:
- No abnormalities were revealed at the macroscopic examination at study termination on Day 15.
Any other information on results incl. tables
Individual and group mean bodyweights (g)
Dose |
Sex |
Animal |
Bodyweight (g) at Day |
||
1* |
8 |
15 |
|||
2000 |
Male |
GG4 |
103 |
153 |
187 |
GG5 |
108 |
161 |
200 |
||
GG6 |
104 |
166 |
218 |
||
Mean |
105 |
160 |
202 |
||
Female |
GGI |
86 |
128 |
145 |
|
GG2 |
92 |
138 |
164 |
||
GG3 |
85 |
132 |
159 |
||
Mean |
88 |
133 |
156 |
* Prior to dosing
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal oral dose to rats of DV6850 was demonstrated to be greater than 2000 mg/kg bodyweight in accordance with OECD Guideline No. 423. DV6850 is in accordance with DSD (Directive 67/548/EEC) or CLP Regulation (EC) No 1272/2008 "unclassified" and will not require labelling
- Executive summary:
This study was performed to assess the acute oral toxicity of DV6850 to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 96/54/EEC (Official Journal No, L248, 30,9,96). Part B, Method B.1 tris, "Acute toxicity (oral) - acute toxic class method" and OECD Guideline for Testing of Chemicals No.423 “Acute Oral Toxicity - Acute Toxic Class Method” Adopted 22 March 1996.
A group of three fasted female rats received a single oral gavage dose of the test substance, formulated in water for irrigation, at a dose level of 2000 mg/kg. As results at this dosage indicated the acute lethal oral dose of the test material to be greater than 2000 mg/kg bodyweight, in compliance with the study guidelines, a group of three fasted males was dosed at 2000 mg/kg to confirm results at this dosage and complete the study.
All animals were killed as scheduled and examined macroscopically on Day 15, the end of the observation period. No clinical signs of reaction to treatment were observed in any animal throughout the duration of the study. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were revealed at the macroscopic examination at study termination on Day 15.
The acute lethal oral dose to rats of DV6850 was demonstrated to be greater than 2000 mg/kg bodyweight. DV6850 is in accordance with DSD (Directive 67/548/EEC) or CLP Regulation (EC) No 1272/2008 "unclassified" and will not require labelling.
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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