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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-04-09 to 2008-09-04
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Hungarian Supplier:
WOBE Kereskedelmi Kft.
H-1164, Budapest, Garmada u. 10.
- Age at study initiation: Young adult, 10-11 weeks old, age-matched within one week
- Weight at study initiation: The weight variation in animals involved in the study did not exceed 20 % of the mean weight.
- Housing: Individual caging
- Diet (e.g. ad libitum): Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum
- Water (e.g. ad libitum): tap water from municipal supply, as for human consumption from 500 ml bottle ad libitum
- Acclimation period: 28 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- An irritation/toxicity screen was performed in groups of 2 CBA/Ca mice with test item concentrations of 25 % and 10 % in DMF. This preliminary study was conducted in a similar experimental manner to the exposure phase of the main study. The test item concentrations in the main study ranged from 25-5 %.
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 25 %
- Irritation:
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control substance a-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 14.9, 15.7 and 9.4 at concentrations of 25 %, 10 % and 5 %, respectively. The stimulation index values were compatible with the conventional biological dose-response.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: F 46 Black (25 % in DMF): 14709.9 (per group) F 46 Black (10 % in DMF): 15498.8 (per group) F 46 Black (5 % in DMF): 9296.2 (per group)
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present assay F 46 Black, dissolved in an appropriate solvent up to the maximum feasible concentration (25 %), revealed sensitisation potential (sensitiser) in the local lymph node assay.
- Executive summary:
Based on a local lymph node assay according to EU method B.42 and OECD guideline 429 the test item F 46 Black revealed sensitisation properties.
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