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Diss Factsheets
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EC number: - | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 to 21 September 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to OECD 404 and GLP guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Details on test material:
- Name: Reddish Blue
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species and strain: New Zealand White rabbit
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: 10 weeks
- Weight at study initiation: 2788 to 3061 g
- Housing: single
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 to 21.4°C
- Humidity (%): 46 to 70
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 to 25 September 2009
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): body temperature water
- 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) to slight 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 area of exp.) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1, 2, 3
- Time point:
- other: 24 to 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1, 2, 3
- Time point:
- other: 24 to 72 hours
- Score:
- 0 - 0.33
- Max. score:
- 4
- Irritant / corrosive response data:
- At observation one and 24 hours after patch removal, very slight erythema (score 1) was found in all animals.
At 48 and 72 hours after patch removal, there were no signs of skin irritation observed.
As no local or systemic clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72-hour observation.
The animals’ individual mean scores considering readings at 24, 48 and 72 hours after patch removal for erythema were 0.33, 0.33 and 0.33, respectively.
The animals’ individual mean scores considering readings at 24, 48 and 72 hours after patch removal for oedema were 0.00, 0.00 and 0.00, respectively. - Other effects:
- no mortality, clinical signs of effects on body weights
Any other information on results incl. tables
SCORING OF ERYTHEMA FORMATION
Animal No./ |
Body weight (g) |
1 h |
24 h |
48 h |
72 h |
|
at the beginning |
at the end |
|||||
00575/ M |
2805 |
2893 |
2 |
1 |
0 |
0 |
00546/ M |
3061 |
3135 |
2 |
1 |
0 |
0 |
00559/ M |
2788 |
2840 |
2 |
1 |
0 |
0 |
TOTAL |
- |
- |
6 |
3 |
0 |
0 |
SCORING OF OEDEMA FORMATION
Animal No./ |
Body weight (g) |
1 h |
24 h |
48 h |
72 h |
|
at the beginning |
at the end |
|||||
00575/ M |
2805 |
2893 |
2 |
1 |
0 |
0 |
00546/ M |
3061 |
3135 |
1 |
0 |
0 |
0 |
00559/ M |
2788 |
2840 |
2 |
1 |
0 |
0 |
TOTAL |
- |
- |
5 |
2 |
0 |
0 |
M = male, d = day, h = hour
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Directive 2001/59/EC and Regulation (EC) No 1272/2008, Reddish Blue does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Reddish Blue does not require classification as a skin irritant. - Executive summary:
An acute skin irritation study of the test item Reddish Blue was performed in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 404, 2002).
An amount of 0.5 g of the solid test item was applied neat to the skin of the experimental animals. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin and an adhesive clear plastic patch was applied. The trunk was wrapped in a semi-occlusive clear plastic film with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.
After 4 hours, the remaining test item was removed with water of body temperature.
To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.
There was no mortality or systemic clinical change related to Reddish Blue administration.
There was no effect of treatment on body weight.
At observation one and 24 hours after patch removal, very slight erythema (score 1) as well as very slight oedema (score 1)
was found at the application site in all animals.At 48 and 72 hours after patch removal, there were no signs of skin irritation observed.
As no systemic or local clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72-hour observation.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.33 at all time points.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00 resp. 0.33 at all time points.
According to Directive 2001/59/EC and Regulation (EC) No 1272/2008, Reddish Blue does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Reddish Blue does not require classification as a skin irritant.
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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