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EC number: 286-122-7 | CAS number: 85187-33-3
- 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:
- 27 April 1994 to 22 June 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- other: Annex V, part B of Council Directive 79/831/EEC (Commission Directive 92/69/EEC of July 31, 1992)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
- Cas Number:
- 85187-33-3
- Molecular formula:
- C26H19BrN4Na2O9S3
- IUPAC Name:
- Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identity - FAT 40066/E TE
Batch - SBL009/LR6G (India)
Appearance - brown powder, solid at 20 °C
Smell - neutral
pH-Value - pH-value of a soln. of 2% (w/w) = 5.2
Expiration date - December 18th, 2018
Storage - to be stored at room-temperature
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch number of test material: P.04.36
- Expiration date of the lot/batch: 11/98
- Appearance: Solid
- Storage conditions: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH Chemisch-Pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: 2230 to 2330 g
- Housing: metal cages
- Diet: rabbit pellet - Nafag No. 814, Gossau, Switzerland ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5 g of the test article
- Duration of treatment / exposure:
- 4 h
- Observation period:
- The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system
- Number of animals:
- 3 male rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
The skin reactions observed were reversible until the end of the observation period.
Individual skin reaction scores:
|
Mean Reaction Score |
|||||
Time after exposure hours |
Erythema |
Edema |
||||
|
Animal 1 |
Animal 2 |
Animal 3 |
Animal 1 |
Animal 2 |
Animal 3 |
24 |
1 |
0 |
1 |
0 |
0 |
0 |
48 |
1 |
0 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
Because the mean values of the recordings 24 t o 72 hours after application are below the threshold of significance (2 score for erythema or edema) FAT 40066/C can be classified as non-irritant according to council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40066/C is to be considered as a non-irritant to the skin of rabbits.
- Executive summary:
A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40066/C, on the skin of the New Zealand White rabbits. The study was carried out according to OECD guideline 404. An area of at least 36 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm2) bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm2. A control gauze patch was applied to the contralateral flank. Before application both patches were moistened with distilled water. The patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape.
One animal from treatment group showed erythema till 48 h and one another animal till 24h observation perion. There were no edema observed.
Because the mean values of the recordings 24 t o 72 hours after application are below the threshold of significance FAT 40066/C can be clasified as non-irritant to the skin of rabbits.
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