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EC number: 808-279-8 | CAS number: 88938-51-6
- 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
- Study period:
- From 13. to 28. July 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline; coherence between data, results and conclusions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disperse Blue ANT
- IUPAC Name:
- Disperse Blue ANT
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Disperse Blue ANT
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France Laboratories, Domaine des Oncins B.P. 0109, F 69592 L’Arbresle Cedex, France
- Age at study initiation: approximately 16 weeks
- Weight at study initiation: approximately 5 kg
- Housing: 1 per cage (during the study)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C+/-2 °C
- Humidity (%): 55%+/-15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 13. to 28. July 2015
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated (left) eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Only once. Exposure for 1 hour.
No rinsing of the treated eye was performed after dosing. - Observation period (in vivo):
- 1, 24, 48, 72 hours; 7 and 14 days after dosing.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 1 hour
No rinsing of the treated eye was performed after dosing.
SCORING SYSTEM: Irritation to the cornea, iris and conjunctivae were assigned a numerical value according to the Draize scale.
TOOL USED TO ASSESS SCORE: macroscopic observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- >= 1.7 - <= 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 1 - <= 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight redness (score of 1), well defined chemosis (score of 2) and moderate discharge of the conjunctivae (score of 2) were recorded in all treated animals at the 1 hour post-dose observation. Twenty-four hours after dosing, all animals showed moderate redness, chemosis and discharge (score of 2). Moderate conjunctival redness (score of 2) was observed in all animals at the 48 hour observation. At this examination, slight discharge (score of 1) was noted in two animals (nos. 295 and 303), while moderate discharge (score of 2) was still noted in the remaining animal (no. 305). In addition, slight conjunctival chemosis (score of 1) was noted in two animals (nos. 303 and 305) but well defined chemosis (score of 2) was noted in one animal (no. 295). No conjunctival discharge or chemosis was seen in any animal from 72 hours after dosing onwards. At this examination, redness of the conjunctivae with slight grade (score of 1) was seen in two out of three animals (nos. 295 and 305) and moderate grade (score of 2) in one animal (no. 303). Seven days after treatment (Day 8), one animal only (no. 303) showed slight conjunctival redness (score of 1) while no ocular irritation was noted in the remaining treated animals. Recovery occurred in the remaining animal 14 days after treatment (Day 15). No irritation of the cornea or iris was seen during the whole observation period.
- Other effects:
- A blue staining of the conjunctivae, due to the colour of the substance, was noted in one animal (no. 295) up to 24 hours after treatment and up to 48 hours in two animals (nos. 303 and 305). Blue staining of the fur around the treated eye, due to the colour of the test item, was noted in all animals up to 48 hours after dosing. No signs of pain or distress were observed during the study. There was no indication of a systemic effect.
No relevant changes in body weight were seen during the course of the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A moderate reaction was observed following ocular administration of Disperse Blue ANT (Br) to the rabbit. However, the observed reaction was not sufficient in severity and incidence to require classification. In addition, it was completely reversible over a 14-day observation period in all animals.
- Executive summary:
The acute ocular irritation of Disperse Blue ANT (Br) was investigated in rabbits.
A 0.1 g aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed approximately 1, 24, 48 and 72 hours, 7 and 14 days after dosing.
Slight redness, well-defined chemosis and moderate discharge of the conjunctivae were recorded in all treated animals at the 1 hour post-dose observation. Twenty-four hours after dosing, all animals showed moderate redness, chemosis and discharge. Moderate conjunctival redness was observed in all animals at the 48 hour observation. Slight discharge was noted in two animals, while moderate discharge was still noted in the remaining animal. In addition, slight conjunctival chemosis was noted in two animals and well-defined chemosis was noted in one animal. No conjunctival discharge or chemosis was seen in any animal from 72 hours after dosing onwards. At this examination, redness of the conjunctivae was seen with slight grade in two out of three animals and with moderate grade in one animal. Seven days after treatment (Day 8), one animal showed slight conjunctival redness while no ocular irritation was noted in the remaining treated animals. Recovery occurred in the remaining animal 14 days after treatment (Day 15). No irritation of the cornea or iris was seen during the whole observation period.
A blue staining of the conjunctivae, due to the colour of the substance, was noted in one animal up to 24 hours after treatment and in two animals up to 48 hours after treatment.
There were no signs of pain/distress after dosing.
Changes in body weight were not remarkable.
There was no indication of a systemic effect related to treatment. A moderate reaction was observed following ocular administration of Disperse Blue ANT (Br) to the rabbit. However, the observed reaction was not sufficient in severity and incidence to require classification. In addition, it was completely reversible over a 14-day observation period in all animals.
These results indicate that the test item, Disperse Blue ANT (Br), has no significant effect on the eye of the rabbit. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would suggest the following:
Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required
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