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EC number: 247-269-2 | CAS number: 25797-81-3
- 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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Agency (EPA) $ 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
- Deviations:
- yes
- Remarks:
- (no untreated skin areas to serve as control; exposure period is of 24 h; smaller area of application (i.e., approx. 2.5 cm² gauze pad)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no untreated skin areas to serve as control; exposure period is of 24 h; smaller area of application (i.e., approx. 2.5 cm² gauze pad)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- FAT 20033/L TE
- IUPAC Name:
- FAT 20033/L TE
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 247-269-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 25797-81-3
- Molecular formula:
- C24H23N3O8S2.Na
- IUPAC Name:
- sodium 1-amino-4-({3-[(2-hydroxyethyl)sulfamoyl]-4,5-dimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- powder / dark blue
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 01451.12
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages numbered by ear tags
- Diet: Standard rabbit food - NAFAG, No. 814, Gossau SG (ad libitum)
- Water: ad libitum
- Acclimation period: 4 d
ENVIRONMENTAL CONDITIONS
- Temperature: 22±2 °C
- Humidity: 55±10 %
- Photoperiod (dark / light): 12 h/12 h
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- other: polyethylene glycol (PEG 400) + saline (70 : 30 parts)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL (i.e. 500 mg)
- Concentration (if solution): 50 % - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 d
- Number of animals:
- 6 (i.e., 3 males and 3 females)
- Details on study design:
- TEST SITE:
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland.
EXPOSURE & OBSERVATIONS:
- Gauze patches of 2.5 x2.5 cm laden with 500 mg of the test substance were applied to the prepared abraded and intact skin.
- The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 h application.
- The skin reaction was appraised upon removal and during an observation period of 7 d.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Other effects:
- none
Any other information on results incl. tables
Calculation of the primary skin irritation index:
MEAN REACTION SCORE |
| ||||
Time after exposure hours | e r y t h e m a | edema | |||
intact skin | abraded skin | intact skin | abraded skin | ||
24 | 1.3 | 1.3 | 1.3 | 1.3 | |
72 | 0.5 | 0.7 | 0.5 | 0.7 | |
Total | 1.8 | 2.0 | 1.8 | 2.0 | 7.6 |
Primary irritation index = 7.6 : 4 = 1.9
Due to intensive staining by the test substance erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20033/G was considered to be slightly irritating when applied to intact rabbit skin, however does not meet the EU CLP threshold for classification.
- Executive summary:
An in vivo study was conducted to evaluate the skin irritation potential of the test substance (of ca. 82.2 % purity) in rabbits according to USEPA Guideline 163.81-5 which is similar to OECD Guideline 404 with few deviations. In this study, gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material (i.e. 1 mL of a 50 % solution in polyethylene glycol (PEG 400) and saline (70 : 30 parts)) were applied to the prepared abraded and intact skin of rabbits for 24 h under occlusive conditions. After 24 h, the dressing was removed and the application sites were assessed for oedema and erythema. Further observations were conducted at 48, 72 h, 4 and 7 d. The exposure of FAT 20033/G to intact skin lead to slight irritation in terms of erythema and edema, however the scores obtained were below the mean critical threshold of 2.3 for all the exposed animals. The primary irritation score was calculated to be 1.9. Under the study conditions, the test substance was considered to be slightly irritating when applied to intact rabbit skin. However, responses were confirmed as not exceeding the EU CLP thresholds for triggering classification of skin irritant.
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