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Reaction mass of tetrasodium 8,8'-(1E,1'E)-(4,4'-(cyclohexane-1,1-diyl)bis(4,1-phenylene))bis(diazene-2,1-diyl)bis(7-hydroxynaphthalene-1,3-disulfonate) and trisodium 7-hydroxy-8-((E)-(4-(1-(4-((E)-(1-hydroxy-4-sulfonatonaphthalen-2-yl)diazenyl)phenyl)cyclohexyl)phenyl)diazenyl)naphthalene-1,3-disulfonate
EC number: 942-692-5 | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- constituent 1
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- The complete Read Across Approach is attached at section 13. Source study has reliability 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Remarks:
- pre GLP
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: russian breed.
- Weight at study initiation: 2.2 to 3.2 kg.
- Acclimation period: at least 8 days.
- Housing: animals were housed singly in metal cages (overall dimensions 47×32×34 cm).
- Diet: standard diet of Nafag, ad libitum.
- Water: drinking water, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Relative humidity: 55 ± 5 %
- Photoperiod: 14 hours light/day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g .
VEHICLE
Before application the test material was wetted with tap water. - Duration of treatment / exposure:
- Gauze patches were removed 24 hours after application.
- Observation period:
- 8 day
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Preparation of the trated area: animals were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified immediately before treatment.
- Type of wrap if used: gauze patch of 2.5×2.5 cm laden with the test substance was applied to the prepared skin.The patch was covered with an impermeable foil of 5×5 cm, which was fixed to the body of the animals with adhesive tape.
SCORING SYSTEM
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 approximately 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:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- < 2.3
- Remarks on result:
- other: both intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 hours
- Score:
- < 2.3
- Remarks on result:
- other: both intact and abraded skin
- Irritant / corrosive response data:
- Under the conditions of this experiment, test item was found to be non irritant when applied to the intact or abraded rabbit skin.
Any other information on results incl. tables
Evaluation of the skin reactions - intact skin
Effect | Animal N. | After | |||||
24 hrs | 48 hrs | 72 hrs | 4d | 6d | 8d | ||
Erythema | 114 M | 0 | 0 | 0 | 0 | 0 | 0 |
42 M | 0 | 0 | 0 | 0 | 0 | 0 | |
161 M | 0 | 0 | 0 | 0 | 0 | 0 | |
116 F | 0 | 0 | 0 | 0 | 0 | 0 | |
113 F | 0 | 0 | 0 | 0 | 0 | 0 | |
115 F | 0 | 0 | 0 | 0 | 0 | 0 | |
Oedema | 114 M | 0 | 0 | 0 | 0 | 0 | 0 |
42 M | 0 | 0 | 0 | 0 | 0 | 0 | |
161 M | 0 | 0 | 0 | 0 | 0 | 0 | |
116 F | 0 | 0 | 0 | 0 | 0 | 0 | |
113 F | 0 | 0 | 0 | 0 | 0 | 0 | |
115 F | 0 | 0 | 0 | 0 | 0 | 0 |
Evaluation of the skin reactions - abraded skin
Effect | Animal N. | After | |||||
24 hrs | 48 hrs | 72 hrs | 4d | 6d | 8d | ||
Erythema | 114 M | 0 | 0 | 0 | 0 | 0 | 0 |
42 M | 0 | 0 | 0 | 0 | 0 | 0 | |
161 M | 0 | 0 | 0 | 0 | 0 | 0 | |
116 F | 0 | 0 | 0 | 0 | 0 | 0 | |
113 F | 0 | 0 | 0 | 0 | 0 | 0 | |
115 F | 0 | 0 | 0 | 0 | 0 | 0 | |
Oedema | 114 M | 0 | 0 | 0 | 0 | 0 | 0 |
42 M | 0 | 0 | 0 | 0 | 0 | 0 | |
161 M | 0 | 0 | 0 | 0 | 0 | 0 | |
116 F | 0 | 0 | 0 | 0 | 0 | 0 | |
113 F | 0 | 0 | 0 | 0 | 0 | 0 | |
115 F | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating.
- Executive summary:
Method
The substance was tested for skin irritation according to the patch test technique, as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 6 rabbits of the Russian were shaved one day before treatment with an electric clipper on the flanks and the shaved skin area on the left side was slightly scarified immediately before treatment. Test item was applied to each side in quantities of 0.5 g. Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days.
Results
Under the conditions of the present experiment, the test preparation was found to cause none irritation when applied to intact and abraded rabbit skin. The substance does not cause any signs of irritation.
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