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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:
- 20 December 2010 - 23 December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU, OECD & US EPA test standards in compliance with GLP and reported with a valid GLP certificate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Name: Reactive Blue F08-0170
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
Justification of strain: The New Zealand White rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined approximately one hour before starting the study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
Number of animals: 3 animals
Age of animals at treatment: 12 - 13 weeks old (adult)
Sex: Male
Body weight range at the
beginning of the life phase: 3279 - 3364 g
end of the life phase: 3351 - 3422 g
Date of receipt: 01 December 2010
Acclimatization time: 19 days
Animal identification: The individual identification was by engraved ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.
HUSBANDRY
Number of animal room: 618
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30 - 70%
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
Ventilation: 15-20 air exchanges/hour
The environmental parameters were recorded twice daily during the study.
FOOD AND FEEDING
Animal received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
WATER SUPPLY AND QUALITY CONTROL OF WATER
The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.
The quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). The quality control results are retained in the archives of LAB Research Ltd.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A single dose of 0.1 g of the solid test item Reactive Blue F08-0170 was instilled into the conjunctival sac of the left eye.
- Duration of treatment / exposure:
- The treated eye of the rabbits was rinsed at 1 hour after application with physiological saline solution.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes.
- Number of animals or in vitro replicates:
- 3 male
- Details on study design:
- Clinical Observations and Eye Examination
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill-health were recorded daily.
At the end of the observation period, each animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazine 2% followed by iv. Euthasol 40% anaesthesia. Death was verified by checking pupil and cornea reflex, absence of respiration and pulse.
Scoring and Assessment of Local Reaction
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002).
Classification of the Test Items
Individual reactions of the animal were recorded at each observation time. The nature, severity and duration of all lesions observed were described.
Results were presented and interpreted according to Regulation (EC) No 1272/2008, as follows:
Irreversible effects on the eye/serious damage to eyes (Category 1)
Substances that have the potential to seriously damage the eyes are classified in Category 1 (irreversible effects on the eye). These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight.
Category for irreversible eye effects
If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days;
and/or
— at least in 2 of 3 tested animals, a positive response of:
corneal opacity ≥ 3 and/or
iritis > 1.5
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
Reversible effects on the eye/irritating to eyes (Category 2)
Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).
Category for reversible eye effects
If, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
corneal opacity ≥ 1 and/or
iritis ≥ 1, and/or
conjunctival redness ≥ 2 and/or
conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Measurement of Body Weight
Individual body weight was recorded at the beginning and end of the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 48
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48
- Remarks on result:
- other: The redness values were not described due to the discoloration caused by the test item therefore scoring and evaluation was not performed. The effects were reversible by the 48-hour endpoint.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 48
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: The redness values were not described due to the discoloration caused by the test item therefore scoring and evaluation was not performed. The effects were reversible by the 48-hour endpoint.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 48
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: The redness values were not described due to the discoloration caused by the test item therefore scoring and evaluation was not performed. The effects were reversible by the 48-hour endpoint.
- Irritant / corrosive response data:
- One hour after the application, chemosis (score 1) was observed in two rabbits, discharge (score 1 or 2) was seen in all rabbits, corneal opacity (score 1, area 1) was noted in one rabbit. The conjunctivae was coloured by the test item, therefore there was no possibility to score the conjunctival redness.
At 24 hours after treatment, the conjunctivae was coloured by the test item, therefore there was no possibility to score the conjunctival redness. No other signs of eye irritation were seen.
At 48 hours after treatment there were no signs of eye irritation observed.
At 72 hours after treatment, there were no signs of eye irritation observed. - Other effects:
- No discharge as noted during the study.
Any other information on results incl. tables
Study Code: 10/252-005N Species: NZW Rabbit
Dose: Sex: Male
Start of Exposure: 20 Dec 2010 – Day 0 Test Item: Reactive Blue F08-0170
Time |
Animal No. |
Score of irritation |
IPR |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
||||||
R |
CH |
D |
OD |
OE |
R |
|||||
1 hour |
00887 |
* |
1 |
2 |
0 |
0 |
0 |
0 |
- |
3 |
00612 |
* |
1 |
1 |
0 |
0 |
0 |
0 |
- |
3 |
|
00013 |
* |
0 |
1 |
1 |
1 |
0 |
0 |
- |
3 |
Time of Observation: Day 0
Time |
Animal No. |
Score of irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
24 hours |
00887 |
* |
0 |
0 |
0 |
0 |
0 |
0 |
- |
00612 |
* |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00013 |
* |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Time of Observation: Day 1
Abbreviations: R = Redness OD = Opacity degree of density
CH = Chemosis OE = Extension of opaque area
D = Discharge IPR= Initial pain reaction
- = No data
*: The redness values were not described due to the discoloration caused by the test item therefore scoring and evaluation was not performed.
Time |
Animal No. |
Score of irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
48 hours |
00887 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
00612 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00013 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Time of Observation: Day 2
Time |
Animal No. |
Score of irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
72 hours |
00887 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
00612 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00013 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Time of Observation: Day 3
Abbreviations: R = Redness OD = Opacity degree of density
CH = Chemosis OE = Extension of opaque area
D = Discharge IPR= Initial pain reaction
- = No data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Reactive Blue F08-0170, applied to the rabbits’ eye mucosa, caused significant conjunctival irritant effects at one hour after application. The effects were fully reversible within 24 hours.
According to Regulation (EC) No 1272/2008, Reactive Blue F08-0170 does not require classification as an eye irritant. - Executive summary:
An acute eye irritation study of the test item Reactive Blue F08-0170 was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).
The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A volume of the test item was administered as a single dose.
Individual body weight was recorded at the beginning and end of the study. Morbidity and clinical signs of toxicity were checked daily.The eyes were examined at 1, 24, 48 and 72 hours after the application.
No adverse effects on body weight development were noted during the study period. The general state and behavior of animals were normal throughout the study period.
Eye examination:
During the study, no signs of eye irritation were observed in the control eye of all animals.
Initial Pain Reaction (IPR) (score 3) was observed in all animals after test item administration.
One hour after the application, chemosis (score 1) was observed in two rabbits, discharge (score 1 or 2) was seen in all rabbits, corneal opacity (score 1, area 1) was noted in one rabbit. The conjunctivae was coloured by the test item, therefore there was no possibility to score the conjunctival redness.
At 24 hours after treatment, the conjunctivae was coloured by the test item, therefore there was no possibility to score the conjunctival redness. No other signs of eye irritation were seen.
At 48 hours after treatment, there were no signs of eye irritation observed.
At 72 hours after treatment, there were no signs of eye irritation observed.
As no local or systemic clinical signs were observed 72 hours after test item administration, the study was terminated after the 72-hour observation.
The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
Animal Number
Cornea Opacity
Iris
Conjunctivae
Redness
Chemosis
Discharge
00887
0.00
0.00
0.00*
0.00
0.00
00612
0.00
0.00
0.00*
0.00
0.00
00013
0.00
0.00
0.00*
0.00
0.00
*: Conjunctival redness could not be assessed at 24 hours due to the discoloration caused by the test item. The means scoring is based on the results at 48 and 72 hours.
The test item Reactive Blue F08-0170, applied to the rabbits’ eye mucosa, caused significant conjunctival irritant effects at one hour after application. The effects were fully reversible within 24 hours. Discoloration was reversible within 48 hours.
According to Regulation (EC) No 1272/2008, Reactive Blue F08-0170 does not require classification as an eye irritant.
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.
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