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EC number: 277-429-7 | CAS number: 73398-29-5
- 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
- Study period:
- 06 September 1993 and 20 September 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium 2,2'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[3-bromo-5-butyltoluene-4-sulphonate]
- EC Number:
- 277-429-7
- EC Name:
- Disodium 2,2'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[3-bromo-5-butyltoluene-4-sulphonate]
- Cas Number:
- 73398-29-5
- Molecular formula:
- C36H34Br2N2O8S2.2Na
- IUPAC Name:
- disodium 2-bromo-3-({4-[(2-bromo-4-butyl-6-methyl-3-sulfonatophenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)-6-butyl-4-methylbenzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: dark blue powder
- Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.38 - 2.80 kg
- Housing: The animals were individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 – 23 °C
- Humidity: 54 – 74 %
- Air changes: approximately 15 changes per hour
- Photoperiod: lighting was controlled by a time switch to give 12 hours light and 12 hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (99 mg) - Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- PROCEDURE
- One rabbit was initially treated. A volume of 0.1 mL of the test material, which was found to weigh approximately 99 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released.
- The left eye remained untreated and was used for control purposes.
- Immediately after administration of the test material, an assessment of the initial pain reaction was made.
- After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
SCORING SYSTEM:
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").
- Any other ocular effects were also noted. Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.
- Additional observations were made on days five, seven and fourteen to assess the reversibility of the ocular effects.
DRAIZE SCALE FOR SCORING OCULAR IRRITATION
CONJUNCTIVAE
(A) 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
(B) 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 half closed to completely closed = 4
(C) 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 a considerable area around the eye = 3
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
2. IRIS
(D) Values
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, haemorrhage, gross destruction (any or all of these) = 2
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
3. CORNEA
(E) Degree of Opacity (most dense area used)
No opacity = 0
Scattered or diffuse areas, 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
(F) Area of Cornea involved
One quarter (or less) but not zero = 1
Greater then 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
THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL - 80
MAXIMUM TOTAL SCORE POSSIBLE = 110
INTERPRETATION OF RESULTS
- The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:
Score for conjunctivae = (A+ B + C) x 2
Score for iris = D X 5
Score for cornea = (E X F) X 5
- Using the numerical data obtained a modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem., 1962 13 281-289 was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material. The results were also interpreted according to Commission Directive 91/325/EEC which adapts Council Directive 67/548/EEC on the regulations relating to the classification, packaging and labelling of dangerous substances, as follows:
- Interpretation according to Annex VI Part II {B) Eve Irritation
Criteria: The test material will be classified as irritant and will require the appropriate "Xi" symbol if ocular lesions occur within 72 hours after exposure, persist for at least 24 hours and correspond to one or more of the following mean values in two or more animals:
- corneal opacity: 2 or more
- iridial lesion: 1 or more
- redness of conjunctivae: 2.5 or more
- chemosis of conjunctivae: 2 or more
The 24, 48 and 72-hour readings for each animal will be used to calculate the mean values.
If these criteria are not satisfied the test material will be classified as non-irritant.
- Interpretation according to Annex VI Part II (D)
In addition the following risk (R) phrases will be assigned to the test material, if appropriate, according to the criteria indicated below:
R 36 IRRITATING TO EYES: If, when applied to the eye of three rabbits, significant ocular lesions are caused which are present 24 hours or more after the instillation of the test material in two or more animals. Ocular lesions are significant if the mean of the 24, 48 and 72-hour readings comply with any of the following criteria:
- corneal opacity: equal to or greater than 2 but less than 3
- iridial lesion: equal to or greater than 1
- conjunctival redness: equal to or greater than 2.5
- conjunctival chemosis: equal to or greater than 2
R 41 RISK OF SERIOUS DAMAGE TO EYES: If, when applied to the eye of three rabbits, severe ocular lesions are caused in two or more animals which are present 24 hours or more after instillation of the test material. Ocular lesions are severe if the mean of the 24, 48 and 72- hour readings comply with either of the following criteria:
- corneal opacity: equal to or greater than 3
- iridial lesion: equal to 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 115 Female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 3 Female
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 101 Female
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 115 Female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 101 Female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 115 Female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 3 Female
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 101 Female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 115 Female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 3 Female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 101 Female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Irritant / corrosive response data:
- - Residual test material was noted around the treated eye of all animals throughout the study.
- Blue-coloured staining was noted in all treated eyes during the study.
- Blue-coloured staining prevented accurate evaluation of the cornea in one treated eye one hour after treatment. A dulling of the normal lustre of the corneal surface was noted in two treated eyes one hour after treatment. Areas of diffuse corneal opacity were noted in all treated eyes at the 24-hour observation with areas of diffuse to translucent corneal opacity at the 48 and 72-hour observations. Areas of opalescent corneal opacity were noted in one treated eye at the 5-day observation. Areas of diffuse or opalescent corneal opacity were noted in two treated eyes at the 7-day observation. Opalescent corneal opacity over approximately 50 % of the cornea with diffuse to translucent corneal opacity in the remaining area was noted in one treated eye at the 14-day observation. Vascularisation of the cornea was noted in one treated eye at the 5-day observation, in two treated eyes at the 7-day observation and in one treated eye at the 14-day observation.
- Blue-coloured staining prevented accurate evaluation of the iris in one treated eye one hour after treatment. Iridial inflammation was noted in two treated eyes one hour after treatment, in all treated eyes at the 24, 48, 72-hour and 5 or 7-day observations and in one treated eye at the 14-day observation.
- Blue-coloured staining prevented accurate evaluation of conjunctival redness in all treated eyes one hour after treatment. Slight to severe conjunctival chemosis and discharge were noted in all treated eyes at this time. Moderate conjunctival irritation was noted in all treated eyes at the 24, 48, 72-hour and 5 or 7-day observations. Moderate conjunctival irritation was noted in one treated eye at the 14-day observation. Ectropion was noted in one treated eye at the 5-day observation and in another treated eye at the 7-day observation.
- The animals were showing signs of pain and discomfort and were therefore killed for humane reasons immediately after the 5, 7 or 14-day observations in accordance with current UK Home Office guidelines.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU criteria: Causes serious eye damage
- Conclusions:
- Under the conditions of this study, the test material was irritating to the eye.
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the standardised guidelines OECD 405 and EU Method B5, under GLP conditions.
One rabbit was initially treated. A volume of 0.1 mL of the test material, which was found to weigh approximately 99 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Blue-coloured staining prevented accurate evaluation of the cornea in one treated eye one hour after treatment. A dulling of the normal lustre of the corneal surface was noted in two treated eyes one hour after treatment. Areas of diffuse corneal opacity were noted in all treated eyes at the 24-hour observation with areas of diffuse to translucent corneal opacity at the 48 and 72-hour observations. Areas of opalescent corneal opacity were noted in one treated eye at the 5-day observation. Areas of diffuse or opalescent corneal opacity were noted in two treated eyes at the 7-day observation. Opalescent corneal opacity over approximately 50 % of the cornea with diffuse to translucent corneal opacity in the remaining area was noted in one treated eye at the 14-day observation. Vascularisation of the cornea was noted in one treated eye at the 5-day observation, in two treated eyes at the 7-day observation and in one treated eye at the 14-day observation.
The animals were showing signs of pain and discomfort and were therefore killed for humane reasons immediately after the 5, 7 or 14-day observations in accordance with current UK Home Office guidelines.
Under the conditions of this study, the test material was irritating to the eye.
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