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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-07-11 to 2003-03-03
- 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:
- OECD Guideline 402 (Acute Dermal Toxicity)
- 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):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: 8-12 weeks
- Weight at study initiation: 188 to 228 g
- Housing: individually in metal cages (RS Biotech Sub-Dividable Rodent Cages - polished stainless steel)
- Diet (e.g. ad libitum): standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours of continuous artificial light in each 24-hour period
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers taking care to avoid damaging the skin, exposing an area equivalent to approximately 10% of the total body surface area.
- % coverage: approximately 50 mm x 50 mm was covered with substance
- Type of wrap if used: covered with porous gauze held in place with a non-irritating dressing and further covered by a waterproof dressing encircled firmly around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated area of skin was washed with warm water (30 - 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- Concentration (if solution): 20% test substance
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observation. The bodyweight was recorded on day 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, dermal responses, body weight, organ weights
- Scoring System for dermal observations:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to eschar formation (injuries in depth): 4
Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: - no systemic response - Very slight to moderate to severe dermal irritation (Grade 1 to 3 erythema with or without Grade 1 or 2 oedema) was observed in all animals following removal of the dressings, resolving completely by either Day 7 in males and Day
- Gross pathology:
- Dryness of the dose site was seen at the macroscopic examination of one male and three females with scabbing of the dose site seen in four females. No other abnormalities were revealed at the macroscopic examination at study termination on Day 15.
Any other information on results incl. tables
Table 1 - Dermal reactions
Dose |
Sex |
Animal |
E=Erythema O=Oedema |
Day |
|||||||||||
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 to 15 |
||||
2000 |
Male |
CCI |
E |
1 |
1a |
1a |
0a |
0a |
0a |
0a |
0 |
0 |
0 |
0 |
0 |
O |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
CC2 |
E |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
CC3 |
E |
1 |
1 |
1 |
1a |
0a |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
O |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
CC4 |
E |
2 |
1 |
1 |
1a |
0a |
0 |
0 |
0a |
0a |
0a |
0 |
0 |
||
O |
1 |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
CC5 |
E |
2 |
1a |
1a |
1a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
||
O |
1 |
2 |
1 |
1 |
1 |
0b |
0b |
0 |
0 |
0 |
0 |
0 |
|||
Female |
CC6 |
E |
2 |
2 |
2a |
1a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
|
O |
1 |
2 |
1 |
1 |
1 |
1b |
1b |
0b |
0b |
0b |
0b |
0b |
|||
CC7 |
F |
3 |
2 |
2a |
2a |
1a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
||
O |
2 |
2 |
2 |
1 |
1 |
1b |
0b |
0b |
0b |
0b |
0b |
0b |
|||
CC8 |
E |
2 |
2 |
2a |
1a |
0a |
0a |
0a |
0 |
0 |
0 |
0 |
0 |
||
O |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
CC9 |
E |
1 |
1 |
1a |
1a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
0b |
||
O |
1 |
1 |
1 |
1 |
1 |
0b |
0b |
0b |
0b |
0b |
0b |
0 |
|||
CC10 |
E |
1 |
1 |
1a |
1a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
0a |
||
O |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0b |
0b |
0b |
a Desquamation (characterised by dryness/exfoliation)
b Spots and/or scabbing (confined to small area of dose site)
Table 2- Individual and group mean bodyweights (g)
Dose |
Sex |
Animal |
Bodyweight (g) at Day |
||
1* |
8 |
15 |
|||
2000 |
Male |
CC1 |
200 |
236 |
275 |
CC2 |
190 |
224 |
260 |
||
CC3 |
192 |
223 |
253 |
||
CC4 |
188 |
232 |
289 |
||
CC5 |
201 |
238 |
277 |
||
Mean |
194 |
231 |
271 |
||
Female |
CC6 |
228 |
238 |
251 |
|
CC7 |
220 |
231 |
237 |
||
CC8 |
209 |
221 |
238 |
||
CC9 |
207 |
207 |
207 |
||
CC10 |
206 |
212 |
225 |
||
Mean |
214 |
222 |
232 |
* 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 dermal 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
- Executive summary:
A study was performed to assess the acute dermal toxicity of DV6850 to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (Official Journal No. L383A, 29.12_92), Part B, Method B3. "Acute toxicity (dermal)" and OECD Guideline for Testing of Chemicals No, 402 "Acute Dermal Toxicity". Adopted: 24 February 1987.
A group of ten rats (five males and five females) received a single topical application of the test substance, in water for irrigation, at a dose level of 2000 mg/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.
There were no deaths and no systemic response to treatment in any animal throughout the study.
Very slight to moderate to severe dermal irritation (Grade 1 to 3 erythema with or without Grade 1 or 2 oedema) was observed in all animals following removal of the dressings, resolving completely by either Day 7 in males and Day 9 in females. In addition, desquamation (characterised by dryness/exfoliation) was seen in four males and all females from Day 3, resolving in three males by Day 12 and two females by Day 14 and persisting in one male and three females until study termination on Day 15. Spots and/or scabbing (confined to a small area of the dose site) were also observed in one male and four females from Day 7, resolving in the male by Day 9 and persisting in all the females until study termination on Day 15.
No bodyweight gain was recorded for one female on both Day 8 and Day 15. A notably low bodyweight gain was seen in one female on Day 8 and one female on Day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Dryness of the dose site was seen at the macroscopic examination of one male and three females with scabbing of the dose site seen in four females. No other abnormalities were revealed at the macroscopic examination at study termination on Day 15.
The acute lethal dermal 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
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