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EC number: 215-385-2 | CAS number: 1324-76-1
- 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:
- from to February 15, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline test with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pigment Blue 61
- IUPAC Name:
- Pigment Blue 61
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Pigment Blue 61 (61DT6100), Batch# 9241902
Supplied by:Flint Group
Date Received:10/11/10
Storage:Room temperature and humidity
Description:Blue Powder
Sample Preparation:The test article was used as received.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand White rabbits were received from Myrtle's Rabbitry, inc., Thompsons Station TN on 10/07/10 and acclimated for at least five days. Only animals in apparent good health were made available for study assignment. Prior to being selected for this study, both eyes of each animat were examined according to the Draize technique for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva. A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in the examination. Three rabbits (1 male - 2 females), free from evidence of ocular irritation or abnormalities, were assigned to this study without conscious bias.
The animals were born on 06/28/10. The pretest body weight range was 2.7 - 2.9 kg. The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended cages. Paper bedding was placed beneath the cages and changed at least three times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12-hour light/dark cycle and was kept clean and vermin free.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye
- Amount / concentration applied:
- The test article (0.1 ml equivalent (23.4 mg)) was placed by syringe-type applicator into the conjunctival sac that was formed by gently pulling the lower eyelid away from the eye. After insWlation, the lids were held together for approximately one second to insure adequate distribution of the test article.
- Duration of treatment / exposure:
- approximately one second
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and again on day 7 postdose
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- Dosing
The test article (0.1 ml equivalent (23.4 mg)) was placed by syringe-type applicator into the conjunctival sac that was formed by gently pulling the lower eyelid away from the eye. After insWlation, the lids were held together for approximately one second to insure adequate distribution of the test article. One eye of each rabbit was dosed. The contralateral eye served as a control.
Type and Frequency of Observations
Using a Mini-Magiite® flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours and again on day 7 postdose. The control eyes were observed at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique. Additional signs were described.
Body weights were recorded pretest and at termination.
Observations for toxicity and pharmacological effects were recorded at each ocular observation period and mortality observations were performed daily. All animals were humanely sacrificed using C02 following study termination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 48hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 48hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 72hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 48hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48hours
- Irritant / corrosive response data:
- There was no cornea! opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared in one eye by 48 hours, in one eye by 72 hours and in one eye by day 7.
The control eyes appeared normal at all observation periods. - Other effects:
- There were no abnormal physical signs noted during the observation period.
Body weights increased in two animals and stayed the same in one animal.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions, test article caused mildly irritating to rabbit's eyes.
- Executive summary:
This study was performed to investigate the irritant or corrosive effects of test article when applied to the eyes of a rabbit. This study was designed to comply with GLP regulations and OECD guideline 405. Three healthy New Zealand White rabbits(1 male, 2 females) were dosed with test article. Test article(0.1 ml equivalent 23.4 mg) was placed into the conjunctival sac of one eye of each rabbit for 4 hours. The eyes were examined pretest and scored by the Draize technique at 1,24, 48 and 72 hours and again on day 7 postdose. The contral eyes were observed at the same time periods. Animals were also observed for toxicological effects at each dermal observation period and observed for mortality daily.There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared in one eye by 48 hours, in one eye by 72 hours and in one eye by day 7.
The control eyes appeared normal at all observation periods.There were no abnormal physical signs noted during the observation period.
Therefore, test article is considered to be only mildly irritating to rabbit's eyes as the mean scores of conjunctival irritation < 2 (following grading at 24, 48 and 72 hours after installation of the test material), and which fully reverses within an observation period of 7 days.
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