Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 274-434-6 | CAS number: 70210-37-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to internationally accepted testing guidelines.
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 Food, 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:
- Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate
- EC Number:
- 274-434-6
- EC Name:
- Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate
- Cas Number:
- 70210-37-6
- Molecular formula:
- C30H21N3O9S2.2Na
- IUPAC Name:
- disodium (E)-5-benzamido-4-hydroxy-3-((2-(otolyloxy)phenyl)diazenyl)naphthalene-2,7-disulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Russian breed
- Housing: cages
- Diet and water: standard diet of Nafag and drinking water ad libitum.
Only rabbits showing normal ophthalmic findings were included in the test.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held
open for a few seconds. - Duration of treatment / exposure:
- The eyes of 3 animals were rinsed 1 minute after application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females) rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiologic saline
- Time after start of exposure: 1 minute
TOOL USED TO ASSESS SCORE: hand-slit lamp
SCORING SYSTEM: the reactions were appraised after 1 and 6 hours; 1, 2, 3, 6 and 8 days on the basis of the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
CORNEA
- Opacity-degree of density (area most dense taken for reading)
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4
- Area of cornea involved
One quarter (or less) but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
IRIS
Normal: 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAE
- Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3
- Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4
- Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- The substance was found to cause transient minimal to slight irritation in un-rinsed and minimal irritation in rinsed eyes, in both cases after 6 hours. The irritation consisted of conjunctival reaction. Reflective hyperemia of the iris was observed 6 hours after installation in 1/3 unrinsed eyes only.After 24 hours, there was complete recovery in 2/3 unrinsed and 3/3 rinsed eyes.
Any other information on results incl. tables
time | 1 hour | 6 hours | |||||||||||
Eye, left/right | not rinsed | rinsed after 1 minute | not rinsed | rinsed after 1 minute | |||||||||
Animal n. | 142 | 107 | 143 | 152 | 140 | 191 | 142 | 107 | 143 | 152 | 140 | 191 | |
cornea | opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
area involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
conjunctivae | redness | 2 | 2 | 1 | 1 | 2 | 2 | 1 | 2 | 2 | 1 | 1 | 2 |
chemosis | 1 | 2 | 1 | 0 | 1 | 1 | 1 | 2 | 1 | 0 | 0 | 1 | |
discharge | 2 | 3 | 1 | 1 | 1 | 2 | 1 | 2 | 1 | 0 | 0 | 1 |
time | 24 h | 48 h | |||||||||||
Eye, left/right | not rinsed | rinsed after 1 minute | not rinsed | rinsed after 1 minute | |||||||||
Animal n. | 142 | 107 | 143 | 152 | 140 | 191 | 142 | 107 | 143 | 152 | 140 | 191 | |
cornea | opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
area involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
conjunctivae | redness | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
discharge | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
time | 72 h | 6 days | 8 days | ||||||||||||||||
Eye, left/right | not rinsed | rinsed after 1 minute | not rinsed | rinsed after 1 minute | not rinsed | rinsed after 1 minute | |||||||||||||
Animal n. | 142 | 107 | 143 | 152 | 140 | 191 | 142 | 107 | 143 | 152 | 140 | 191 | 142 | 107 | 143 | 152 | 140 | 191 | |
cornea | opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
area involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
conjunctivae | redness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
discharge | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating
- Executive summary:
METHOD
The eye irritation test was performed to rabbit eye using a single administration, according to the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
RESULT
The substance was found to cause minimal to slight irritation when applied to the rabbit eye mucosa. The substance was found to cause transient minimal to slight irritation in un-rinsed and minimal irritation in rinsed eyes, in both cases after 6 hours (during the test, the eyes of three animals were rinsed 1 minute after application, with physiologic saline solution). The irritation consisted of conjunctival reaction. Reflective hyperemia of the iris was observed 6 hours after installation in 1/3 unrinsed eyes only. After 24 hours, there was complete recovery in 2/3 unrinsed and 3/3 rinsed eyes.
CONCLUSION
The criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline. Nevertheless, the scoring system used for the cornea opacity and degree of density, for the iris and conjunctivae redness and chemosis are the same of that reported into the OECD. Since the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC n. 1272/2008).
The mean values at 24, 48 and 72 hours for both rinsed and unrinsed eyes were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.
Therefore, the test substance can be classified as NON IRRITATING, according to the CLP Regulation (EC n. 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.