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EC number: 240-400-4 | CAS number: 16324-27-9
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Internationally accepted guideline, well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- The procedure used is described in the 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.
- GLP compliance:
- no
- Remarks:
- Pre GLP
Test material
- Reference substance name:
- Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 240-400-4
- EC Name:
- Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 16324-27-9
- Molecular formula:
- C36H32N12Na4O14S4
- IUPAC Name:
- Tetrasodium 2,2'-[(E)-1,2-ethenediyl]bis[5-({4-[(2-hydroxyethyl)amino]-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland.
- Age at study initiation: adult, age not specified.
- Weight at study initiation: 2 to 3 kg.
- Housing: housed individually in metal cages.
- Diet: ad libitum, standard rabbit food - NAFAG, No. 814, Gossau SG.
- Water: ad libitum.
- Acclimation period: prior to treatment they were adapted to our laboratories for a minimum of 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Photoperiod: 10 hours light cycle day.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded.
- Amount / concentration applied:
- TEST MATERIAL
- Application: gauze patches of 2.5 x 2.5 cm laden with test substance.
- Amount of test substance: 0.5 ml. - Duration of treatment / exposure:
- The dressing were removed after a 24 hours exposure.
- Observation period:
- 7 days
- Number of animals:
- 3 male and 3 female.
- Details on study design:
- TEST SITE
- Area of exposure: 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.
- Type of wrap if used: the patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
SCORING SYSTEM
The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme.
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
Maximum 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 approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible erythema score: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- Test substance was found to cause a minimal irritation when applied to intact and abraded rabbit skin.
Any other information on results incl. tables
Evaluation of the skin reactions
Intact skin
Animal/sex | Reaction | 24 hrs | 48 hrs | 72 hrs | 4 days | 7 days | Mean 24, 48 and 72 hrs | |
274 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | |
275 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | |
276 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | |
277 F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | |
278 F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | |
279 F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | |
274 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 | |
275 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 | |
276 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0 | |
277 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0 | |
278 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0 | |
279 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0 |
Abraded skin
Animal/sex | Reaction | 24 hrs | 48 hrs | 72 hrs | 4 days | 7 days | Mean 24, 48 and 72 hrs | |
274 M | Erythema | 0 | 0 | 0 | 0 | 0 | 0.00 | |
275 M | Erythema | 1 | 1 | 0 | 0 | 0 | 0.67 | |
276 M | Erythema | 1 | 0 | 0 | 0 | 0 | 0.33 | |
277 F | Erythema | 1 | 1 | 0 | 0 | 0 | 0.67 | |
278 F | Erythema | 1 | 1 | 0 | 0 | 0 | 0.67 | |
279 F | Erythema | 2 | 2 | 1 | 0 | 0 | 1.67 | |
274 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | |
275 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | |
276 M | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | |
277 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | |
278 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 | |
279 F | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Non irritating.
- Executive summary:
Method
The test was conducted following the procedures described in the 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.
Results
Test substance was found to cause a minimal irritation when applied to intact and abraded rabbit skin.
Conclusion
According to the CLP Regulation (EC 1272/2008), test substance can be classified as non irritating. The mean value scored is less than 2.3 for erythema/eschar and for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal, in both the cases of intact and abraded skin.
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