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Diss Factsheets
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EC number: 471-920-1 | 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:
- 2004_06_15 to 2006_02_03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2002-12-02
Test material
- Details on test material:
- - Physical state: dark amber slightly viscous liquid
- Analytical purity: No data
- Stability under test conditions: undetermined
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr):at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light: 12 hours dark
IN-LIFE DATES: From: 2005-10-27 To: 2005-11-10
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated site on test animals used as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): Applied as supplied - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours, 7 and 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cotton gaze secured with surgical adhesive tape and wrapped with elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbed with cottn wool soaked in liquid paraffin.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Well defined erythema was noted at one treated site with very slight erythema at the two remaining skin sites one hour aftre patch removal. Well-defined erythema was noted at all treated skin sites at the 24, 48 and 72-hour observations.
Very slight oedema was noted at all treated skin sites one hour after ptch removal and at the 24, 48 and 72-hour observations.
Light brown discolouration was noted at all treated skin sites at the 72-hour observation with crust formation noted at the 7-day observation.
All treated skin sites appeared normal at the 14-day observation.
Any other information on results incl. tables
Table 1: Individual Skin Reactions – Test sites
Skin reaction |
Observation time |
Individual scores – Rabbit number and sex |
Total |
||
153 male |
154 Male |
155 Male |
|||
Erythema/Eschar formation |
1 hour |
2 |
1 |
1 |
(4) |
24 hours |
2 |
2 |
2 |
6 |
|
48 hours |
2Br |
2 |
2 |
(6) |
|
72 hours |
0Cf |
2Br |
2Br |
6 |
|
7 days |
0 |
0Cf |
0Cf |
(0) |
|
14 days |
1 |
0 |
0 |
(0) |
|
Oedema formation |
1 hour |
1 |
1 |
1 |
(3) |
24 hours |
1 |
1 |
1 |
3 |
|
48 hours |
1 |
1 |
1 |
(3) |
|
72 hours |
0 |
1 |
1 |
3 |
|
7 days |
0 |
0 |
0 |
(0) |
|
14 days |
0 |
0 |
0 |
(0) |
|
Sum of 24 and 72-hour readings |
18 |
||||
Primary Irritation Index (S/6) |
18/6 = 3.0 |
||||
Classification |
MODERATE IRRITANT |
( ) = Total values not used for calculation of primary irritation index
Br = Light brown discoloration of the epidermis
Cf = Crust formation
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material does not meet the criteria for classification as a skin irritant as defined in the EU CLP Regulation (EC) No. 1272/2008 under the conditions of the study.
- Executive summary:
Test Guidance
OECD Guideline No. 404 and EC Method B4
Method and materials
0.5 mL of the test material was applied as supplied to the shaved skin of three albino New Zealand rabbits. An untreated site on the rabbits served as a control. After 4 hours exposure the semiocclusive wrapping was removed and treated sites washed with liquid paraffin. Irritation was recorded using the Draize scale at 1, 24, 48 and 72 hour time points and thereafter at 7 and 14 days.
Results
Application of the test material produced well-defined erythema and very slight oedema. Other skin reactions noted were light brown discolouration of the epidermis and crust formation. All treated skin sites appeared normal at the 14 -day observation.
No evidence of skin irritation was observed on the control patches of the three rabbits.
Under EU Directive 2001/59/EC the test material was labelled as Xi, R38 Irritating to skin.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
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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