Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
The test item DV6850 was determined to be irritating to the skin. It is not irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2 October 2002 to 7 November 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: >= 8 weeks
- Weight at study initiation: 2.84 - 3.07 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet (e.g. ad libitum): 125 g/day standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellets ), dietary supplement of hay
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >= 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C. The study protocol indicated that the target temperature range was 15-23°C, however, the range was changed to 16-20°C on 4th November 2002. The change was to accord with the UK Home Office Animals (Scientific Procedures) Act 1986 Code of Practice for the Housing and Care of Animals used in Scientific Procedures (1989).
- Humidity (%): 40-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours continuous artificial light in each 24 hour period - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Intact skin, clipped hair
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The treatement site was wetted with 0.5 mL of reverse osmosis water.
- Controls:
- other: An additional site of the test animals was similarly treated with the exception of test substance and acted as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g on wetted skin - Duration of treatment / exposure:
- 4 hours (a single animal received three exposures (of three minutes, one or four hours duration) in a step-wise manner and acted as a preliminary screen)
- Observation period:
- 15 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: On the day before application of the test substance, hair was removed with clippers from the dorso-lumbar region of each rabbit exposing an appropriate sized area of skin.
- % Coverage: approximately 25 mm x 25 mm was covered with substance
- Type of wrap if used: Test substance was applied under a 2-ply porous gauze pad. For exposures of one hour or more each treatment site was covered with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period.
- Preparation of test site: The skin treatment site was wetted with 0.5 mL of water before application of the powder.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
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) or 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 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Very-slight to moderate to severe erythema with or without very-slight or, in one case, slight oedema was apparent during the first week after bandage removal, persisting in two cases until termination on Day 15. Loss of flexibility was evident in two animals 72 hours after bandage removal and in one case on Day 8; eschar formation or exfoliation was apparent in two animals on Day 8 or 15.
- Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Although the mean scores were below the labelling threshold of Commission Directive 2001 /59/EC the persistent nature of the treatment related findings in two cases indicates significant irritation. Accordingly, DV6850 required labelling with the risk phrase R38, "Irritating to skin" (DSD) or Skin irrit. 2, H315 (CLP).
- Executive summary:
A study was performed to assess the skin irritation potential of DV6850 to the rabbit. The methods followed were 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 B.4. Acute toxicity (Skin Irritation), OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion", adopted 17 July 1992 and EPA Health Effects Test Guidelines OPPTS 870.2500 Acute Dermal Irritation EPA 712 -C-98-196, August 1998.
Three rabbits received a single four hour, semi-occlusive, dermal administration of approximately 0.5 g of the test substance as supplied on wetted skin and were observed for fifteen days.
Very-slight to moderate to severe erythema with or without very-slight or, in one case, slight oedema was apparent during the first week after bandage removal, persisting in two cases until termination on Day 15. Loss of flexibility was evident in two animals 72 hours after bandage removal and in one case on Day 8; eschar formation or exfoliation was apparent in two animals on Day 8 or 15. Mean individual scores at 24, 48 and 72 h after application were 2.7, 1.3, 1.0 for erythema and 1.0, 1.3, 1.0 for edema, for rabbits No. 1, 2, 3, respectively. Although the mean scores were below the labelling threshold of Comission Directive 2001 /59/EC the persistent nature of the treatment related findings in two cases indicates significant irritation. Accordingly, DV6850 required labelling with the risk phrase R38, "Irritating to skin" (DSD) or Skin irrit. 2, H315 (CLP).
Reference
Table 1 - Scoring of irritance responses
Test site: 0.5 g DV6850, semi occluded for four hours, dorso lumbar
Control site: No treatment
Animal number and sex |
Type of response |
1 hour |
24 hours |
48 hours |
72 hours |
Day 8 |
Day 15 |
||||||
Test site |
Control site |
Test site |
Control site |
Test site |
Control site |
Test site |
Control site |
Test site |
Control site |
Test site |
Control site |
||
4617 M * |
Erythema |
0 |
0 |
2 |
0 |
3 |
0 |
3 |
0 |
1 Lf |
0 |
0 |
0 |
Oedema |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
|
4660 M |
Erythema |
1 |
0 |
1 |
0 |
1 |
0 |
2 Lf |
0 |
2 E |
0 |
1 D |
0 |
Oedema |
0 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
1 |
0 |
1 |
0 |
|
4662 M |
Erythema |
1 |
0 |
1 |
0 |
1 |
0 |
1 Lf |
0 |
1 D |
0 |
1 D |
0 |
Oedema |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
M: Male
*: Sentinel animal
Lf: Loss of flexibility
D: Exfoliation
E: Eschar
Classification Criteria
The study protocol indicated that the criteria regarding classification, packaging and labelling of dangerous substances of the European Communities as outlined in Directive 93/21/EEC would be employed. However, the updated criteria as documented in 2001/59/EC was employed.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 30 October 2002 to 19 November 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: >= 8 weeks
- Weight at study initiation: 3.12 - 3.60 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet (e.g. ad libitum): 125 g/d of a standard laboratory diet (Special Diet Services STANRAB (P) SQC pellet), dietary supplement of hay until at least two days prior to dose instillation
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >= 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-23°C until 4 November 2002, thereafter 16-20°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
IN-LIFE DATES: From: To: - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL weighing approximately 100 mg - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The substance was not removed.
SCORING SYSTEM:
See Table 1 and Table 2 in "Any other information on materials and methods incl. tables"
TOOL USED TO ASSESS SCORE: An ophthalmoscope and a pencil beam torch were used to facilitate inspection of the eyes. - Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Iridal lesions
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- A crimson-red conjunctival appearance, very-slight discharge and in two cases very-slight chemosis were apparent one hour after instillation. Injection of the conjunctival blood vessels was evident in all animals 24 and 48 hours later; all animals were overtly normal 72 hours after instillation.
- Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DV6850 does not require classification as an eye irritant.
- Executive summary:
A study was performed to assess the eye irritation potential of DV6850 to the rabbit. The methods followed were 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 B.5, acute toxicity (eye irritation), OECD Guideline for the Testing of Chemicals No. 403, "Acute Eye Irritation/Corrosion", adopted 24 February 1987 and EPA Health Effects Test Guidelines OPPTS 870.2400 Acute Eye Irritation EPA 712-C-98-195, August 1998.
Three rabbits were each administered a single ocular dose of a volume of 0.1 mL of the test substance weighing approximately 100 mg and observed for four days after instillation.
A crimson-red conjunctival appearance, very-slight discharge and in two cases very-slight chemosis were apparent one hour after instillation. Injection of the conjunctival blood vessels was evident in all animals 24 and 48 hours later; all animals were overtly normal 72 hours after instillation. Instillation of the test substance gave rise to slight initial pain response. Mean individual scores at 24, 48 and 72 h after application were 0.7, 0.7, 0.7 for conjunctival redness, for rabbits No. 1, 2, 3, respectively, and 0.0 for all other ocular parameters.
DV6850 does not require classification as an eye irritant, according to the criteria of DSD (Directive 67/548/EEC) or CLP (Regulation (EC) 1272/2008).
Reference
Table 1 - Grades for ocular irritation responses following instillation of DV6850
Animal number and sex: 4674 M |
Pain evaluation response: 2 |
|||||||
Region of |
Response |
Grade of response at time after instillation |
||||||
|
|
1 |
24 |
48 |
72 |
|||
Cornea |
Opacity |
0 |
0 |
0 |
0 |
|||
Area |
0 |
0 |
0 |
0 |
||||
Ulceration |
- |
- |
- |
- |
||||
Stippling |
- |
- |
- |
- |
||||
Iris |
Value |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
2 |
1 |
1 |
0 |
|||
Chernosis |
0 |
0 |
0 |
0 |
||||
Discharge |
1 |
0 |
0 |
0 |
||||
Necrosis |
- |
- |
- |
- |
||||
Ulceration |
- |
- |
- |
- |
||||
Animal number and sex: 4733 M |
Pain evaluation response: 2 |
|||||||
Region of |
Response |
Grade of response at time after instillation |
||||||
|
|
1 |
24 |
48 |
72 |
|||
Cornea
|
Opacity |
0 |
0 |
0 |
0 |
|||
Area |
0 |
0 |
0 |
0 |
||||
Ulceration |
- |
- |
‑ |
- |
||||
Stippling |
- |
- |
- |
- |
||||
Iris |
Value |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
2 |
1 |
1 |
0 |
|||
Chemosis |
0 |
0 |
0 |
0 |
||||
Discharge |
1 |
0 |
0 |
0 |
||||
Necrosis |
- |
- |
- |
- |
||||
Ulceration |
- |
- |
- |
- |
||||
Animal number and sex: 4734 M |
Pain evaluation response: 2 |
|||||||
Region of |
Response |
Grade of response at time after instillation |
||||||
|
|
1 |
24 |
48 |
72 |
|||
Cornea |
Opacity |
0 |
0 |
0 |
0 |
|||
Area |
0 |
0 |
0 |
0 |
||||
Ulceration |
- |
- |
- |
- |
||||
Stippling |
- |
- |
- |
- |
||||
Iris |
Value |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
2 |
1 |
1 |
0 |
|||
Chemosis |
1 |
0 |
0 |
0 |
||||
Discharge |
1 |
0 |
0 |
0 |
||||
Necrosis |
- |
- |
- |
- |
||||
Ulceration |
- |
- |
- |
- |
Classification Criteria
The study protocol indicated that the criteria regarding classification, packaging and labelling of dangerous substances of the European Communities as outlined in Directive 93/21/EEC would be employed. However, the updated criteria as documented in 2001/59/EC was employed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The skin irritation and eye irritation potential of the test item DV6850 was assessed in two valid GLP studies according to OECD TG 404 and 405, respectively. To assess the skin irritation potential of the substance, three rabbits received a single four hour, semi-occlusive, dermal administration of approximately 0.5 g of the test substance as supplied and were observed for fifteen days. 24, 48, 72 hours after removal of dressings, erythema and oedema were observed in all animals. The mean scores for erythema were 2.7, 1.3 and 1.0 in animal 1, 2 and 3, respectively, and the mean scores for oedema were 1.0, 1.3 and 1.0. Erythema was still observed in 2 animals and oedema in 1 animal 15 days after exposure.
To assess the eye irritation potential of the substance, three rabbits were each administered a single ocular dose of a volume of 0.1 mL of the test substance weighing approximately 100 mg and observed for four days after instillation. 24 and 48 hours after instillation, no effects except conjunctival redness of the eyes were observed. All animals were overtly normal 72 hours after instillation. The mean scoring of conjunctival redness at 24, 48 and 72 hours was 0.7 for all animals.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
The substance is classified as a skin irritant (Xi; R38 or Skin irrit. 2, H315 according to Directive 67/548/EEC or Regulation (EC) 1272/2008, respectively) because erythema was still observed in 2/3 animals 15 days after exposure.
The substance does not fulfill the criteria for classification as "irritating to eyes" according to Regulation (EC) No 1272/2008 because no effects except conjunctival redness were observed 24, 48 and 72 hours after instillation and the mean scoring of conjunctival redness at these time points was 0.7 for all animals which is below the threshold value for classification (at least 2 of 3 animals with a scoring of >=2 (CLP) or 2.5 (DSD)).
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.