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EC number: 271-351-7 | CAS number: 68541-71-9
- 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:
- 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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- EC Number:
- 271-351-7
- EC Name:
- Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- Cas Number:
- 68541-71-9
- Molecular formula:
- C32H17CrN6O11S.2Na
- IUPAC Name:
- disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
- Test material form:
- other: solid
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Test article: FAT 20011/D
Additional specification: Lanacron Marine S-G roh feucht
Batch No.: 61
Purity/Contents: CA. 52.5 %
Physical properties: solid
Storage conditions: room temperature
Validity: July 1999
Safety precautions: gloves and face masks
Test material received: March 22, 1994
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The test was performed on 3 male rabbits, checked for normal skin conditions, weighing between 2190 to 2310 g. The animals were housed individually in metal cages, identified by ear tattoo, kept at a constant room temperature of 20+/-3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day.
TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: between 2190 to 2310 g
- Housing: The animals were housed individually in metal cages, identified by ear tattoo.
- Diet: The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.
- Water:ad libitum
- Acclimatisation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod: 12 hours light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A control gauze patch moistened with distilled water was applied to the contralateral flank.
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
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 moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
The animals were checked daily for systemic symptoms and mortality (only findings reported).
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
SCORING SYSTEM:
SCORE FOR SKIN IRRITATION IN RABBITS:
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
Total possible erythema score 4
Edema formation
- No edema:..................................................................................................................... 0
- Very slight edema (barely perceptible):............................................................................. 1
- Slight edema (edges of area well defined by definite raising):............................................... 2
- Moderate edema (raised more than 1 mm):........................................................................ 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure:................... 4
Total possible edema score 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- The body weight growth was not affected by the exposure.
Any other information on results incl. tables
Overall results:
3 animals or less | Mean score animal 1* | Mean score animal 2* |
Mean score animal 3* |
Max value |
Maximum duration of any effect |
Max value at the end of the observation period |
Erythema/eschar | 0.33 | 0.33 | 0.33 | 1 | 24 hours | 0 |
Edema | 0 | 0 | 0 | 1 | 1 hour | 0 |
* Calculated on the basis of the scores at 24, 48 and 72 hours for each animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20011/D is not irritating to the rabbit skin.
- Executive summary:
The aim of this study was to determine the potential of FAT 20011/D to cause irritation on skin. The study was carried out according to OECD Guideline 404 and EU Method B.4. An area of at least 36 cm² was shaved on both flanks of the three New Zealand rabbits. A gauze patch 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 moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The mean score for erythema after 24/48/72 hrs was found to be 0.33 and the mean edema score was found to be 0. The skin reactions observed were reversible by 48 h observation. As the mean values of the recordings 24 to 72 hours after application were below the threshold of significance (2 score for erythema or edema) FAT 20011/D can be classified as non-irritant.
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