Registration Dossier
Registration Dossier
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: - | 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July from 18 to 29, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Direct Blue 267
- IUPAC Name:
- Direct Blue 267
Constituent 1
- Specific details on test material used for the study:
- For the purpose of the study the test material was ground to a powder prior to application.
The pH of the test material (10 % w/w aqueous preparation) was determined prior to commencement of the study and found to be 6.6.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: weight range of 2.0 to 3.5 kg.
- Housing: animals were individually housed in suspended cages.
- Diet: certified rabbit diet (Code 5322) supplied by BCM IPS Limited, ad libitum.
- Water: drinking water, ad libitum.
- Acclimation period: at least five days.
- Health check: immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Humidity: 30 to 70 %
- Air changes: at least fifteen changes per hour.
- Photoperiod: lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the test material, which was found to weigh approximately 88 mg
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- APPLICATION
- Schedule: initially, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
- Application: test item 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 treatment, to prevent loss of the test material and then released.
TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
SCORING SYSTEM
Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation from Draize J. H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC pA8 to 49.
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 cornea involved).
Using the numerical data obtained a modified version of the system described by Kay J Hand Calandra J C (1962), J. Soc. Cosmet. Chern. 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.
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) × 2 MAXIMUM TOTAL = 20
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 × 5
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 not discernible through the opacity 4
(F) Area of Cornea Involved
One quarter (or less) but not zero 0
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
THE TOTAL SCORE = (E × F) × 5 MAXIMUM TOTAL = 80
MAXIMUM TOTAL SCORE POSSIBLE = 110
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritant / corrosive response data:
- The test material produced a maximum group mean score of 8.0 and was classified as a mild irritant (class 4 on 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Black staining of the fur was noted around all treated eyes during the study. No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24-hour observation with minimal conjunctival irritation in all treated eyes at the 48-hour observation and in one treated eye at the 72-hour observation.
Two treated eyes appeared normal at the 72-hour observation and the remaining treated eye appeared normal at the 7-day observation.
Any other information on results incl. tables
Individual scores and individual total scores for ocular irritation
Animal no. | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | Mean 24/48/72 hrs |
Male 21 | Cornea | 0 | 0 | 0 | 0 | 0 | 0.00 |
Male 71 | Cornea | 0 | 0 | 0 | 0 | 0 | 0.00 |
Male 72 | Cornea | 0 | 0 | 0 | 0 | 0 | 0.00 |
Male 21 | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
Male 71 | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
Male 72 | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
Male 21 | Conjunctival redness | 2 | 2 | 1 | 1 | 0 | 1.33 |
Male 71 | Conjunctival redness | 1 | 1 | 1 | 0 | 0 | 0.67 |
Male 72 | Conjunctival redness | 1 | 1 | 1 | 0 | 0 | 0.67 |
Male 21 | Conjunctival oedema | 2 | 2 | 1 | 0 | 0 | 1.00 |
Male 71 | Conjunctival oedema | 1 | 1 | 0 | 0 | 0 | 0.33 |
Male 72 | Conjunctival oedema | 1 | 0 | 0 | 0 | 0 | 0.00 |
21 Male, IPR=2 | 71 Male, IPR=2 | 72 Male, IPR=2 | |||||||||||
Time after treatment | 1 hrs | 24 hrs | 48 hrs | 72 hrs | 7 d | 1 hrs | 24 hrs | 48 hrs | 72 hrs | 1 hrs | 24 hrs | 48 hrs | 72 hrs |
Cornea |
|||||||||||||
E = degree of opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
F = area of cornea involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (E × F) × 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Iris |
|||||||||||||
D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (D × 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Conjunctival |
|||||||||||||
A = Redness | 2 | 2 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 0 |
B = Chemosis | 2 | 2 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
C = Discharge | 2Sf | 1Sf | 0Sf | 0Sf | 0Sf | 1Sf | 1Sf | 1Sf | 0Sf | 1Sf | 1Sf | 1Sf | 0 |
Score (A + B + C) × 2 | 12 | 10 | 4 | 2 | 0 | 6 | 6 | 4 | 0 | 6 | 4 | 4 | 0 |
Total Score | 12 | 10 | 4 | 2 | 0 | 6 | 6 | 4 | 0 | 6 | 4 | 4 | 0 |
IPR = Initial pain reaction; 2 means that rabbit blinks and tries to open eye, but reflex closes it; slight initial pain
Sf= Black staining of the fur around the treated eye
Individual total scores and group mean scores for ocular irritation
Individual total scores at | |||||
Rabbit no. | 1 hrs | 24 hrs | 48 hrs | 72 hrs | 7 days |
Male 21 | 12 | 10 | 4 | 2 | 0 |
Male 71 | 6 | 6 | 4 | 0 | - |
Male 72 | 6 | 4 | 4 | 0 | - |
Group total |
24 | 20 | 12 | 2 | 0 |
Group Mean Score |
8.0 | 6.7 | 4.0 | 0.7 | 0.0 |
- = Observation not required
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not eye irritant.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD guideline 405 and the EU Method B5.
A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 72-hour observation and the remaining treated eye appeared normal at the 7-day observation.
The test material produced a maximum group mean score of 8.0 and was classified as a mild irritant (class 4 on 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Black staining of the fur was noted around all treated eyes during the study. No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24-hour observation with minimal conjunctival irritation in all treated eyes at the 48-hour observation and in one treated eye at the 72-hour observation.
Two treated eyes appeared normal at the 72-hour observation and the remaining treated eye appeared normal at the 7-day observation.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of the treated animals. Alle effects were reversible within 7 days.
Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC 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.
