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Diss Factsheets
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EC number: 700-501-0 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-07-09 to 2008-10-15
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- IUPAC Name:
- Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Reference substance name:
- Acid Yellow 42: 6375-55-9
- IUPAC Name:
- Acid Yellow 42: 6375-55-9
- Reference substance name:
- Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
- IUPAC Name:
- Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
- Reference substance name:
- Basic Violet 1: 8004-87-3
- IUPAC Name:
- Basic Violet 1: 8004-87-3
- Details on test material:
- - Name of test material: Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Lot/batch No.: 2008041541
- Expiration date of the lot/batch: 2010-01-31
- Stability under test conditions: see expiry date
- Storage condition of test material: store cool and dry
- Analytical purity: 100 % (96.8 %; UVCB substance)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: TETRABBIT Kft.
2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbit, 12 weeks old
- Weight at study initiation: beginning of the study: 3185-3223 g, end of the study: 3625-3697 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road,
Hungary, ad libitum.
- Water (e.g. ad libitum): tap water from municipal supply as for human consumption via automatic water system ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-20.8 °C
- Humidity (%): 47-88%
- Air changes (per hr): 8-12 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A total volume of 0.1 g of the test item was instilled into the conjunctival sac of the left eye.
- Duration of treatment / exposure:
- Single application. The eyes of test animals were washed out with physiological saline one hour after the test item application
- Observation period (in vivo):
- The eyes were examined at 60 minutes, 24, 48, 72 hours then one, two and three weeks after the treatment.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of test animals were washed out with physiological saline
- Time after start of exposure: 1 hour
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: initial pain reaction (grade 1)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 hrs, 48 hrs, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: area of 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 week
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: area of 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: initial pain reaction (grade 1)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 hrs, 48 hrs, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: area of 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1 week, 2 weeks, 3 weeks
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: area of 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1 hr, 24 hrs, 48 hrs, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: area of 4, initial pain reaction (grade 1)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1 week, 2 weeks, 3 weeks
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: area of 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 2 weeks, 3 weeks
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: area of 4
Any other information on results incl. tables
The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
Animal Number |
Sex |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
8582 |
male |
1.00 |
0.00 |
2.00 |
3.00 |
2.67 |
8181 |
male |
1.00 |
0.00 |
1.33 |
3.00 |
2.67 |
8580 |
male |
1.00 |
0.00 |
2.00 |
3.00 |
3.00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item caused cornea opacity, irreversible within 21 days observation period.
- Executive summary:
In the present study according to EU method B.5 and OECD guideline 405 the test substance F 46 Black caused cornea opacity, irreversible within 21 days observation period.
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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