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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:
- 19 November 2012 to 25 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: off white powder
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: 12 - 20 weeks old
- Weight at study initiation: 2.48 or 2.58 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye of each animal remained untreated and was used for control purposes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, weighing approximately 59 mg (as measured by gently compacting the required volume into an adapted syringe) - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable
SCORING SYSTEM: 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 p.48 to 49
TOOL USED TO ASSESS SCORE: standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Scattered or diffuse corneal opacity was noted in both treated eyes at the 24 and 48-Hour observations and in one treated eye at the 72-Hour observation.
lridial inflammation was noted in both treated eyes one hour after treatment and at the 24, 48 and 72-Hour observations.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Severe conjunctival irritation was noted in one treated eye with moderate conjunctival irritation noted in the other treated eye at the 24-Hour observation. Moderate conjunctival irritation was noted in both treated eyes at the 48 and 72-Hour observations. Moderate conjunctival irritation persisted in one treated eye with minimal conjunctival irritation noted in the other treated eye at the 7-Day observation. Minimal conjunctival irritation was noted in one treated eye at the 14-Day observation.
One treated eye appeared normal at the 14-Day observation and the other treated eye appeared normal at the 21-Day observation. - Other effects:
- Both animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
72696 Male |
72767 Male |
|||||||||||
IPR = 2 |
IPR = 2 |
||||||||||||
Time After Treatment |
1 hr |
24 hr |
48 hr |
72 hr |
7 days |
14 days |
1 hr |
24 hr |
48 hr |
72 hr |
7 days |
14 days |
21 days |
CORNEA E = Degree of Opacity
F = Area of Opacity |
0
0 |
1
2 |
1
2 |
1
1 |
0
0 |
0
0 |
0
0 |
1
1 |
1
1 |
0
0 |
0
0 |
0
0 |
0
0 |
Score (E x F) x 5 |
0 |
10 |
10 |
5 |
0 |
0 |
0 |
5 |
5 |
0 |
0 |
0 |
0 |
IRIS D |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
Score (D x 5) |
5 |
5 |
5 |
5 |
0 |
0 |
5 |
5 |
5 |
5 |
0 |
0 |
0 |
CONJUNCTIVAE A = Redness B = Chemosis C = Discharge |
2 3 2 |
2 3 3 |
2 2 1 |
2 1 1 |
1 1 1 |
0 0 0 |
2 2 3 |
2 2 3 |
2 2 1 |
2 2 1 |
1 2 1 |
1 1 0 |
0 0 0 |
Score (A + B + C) x 2 |
14 |
16 |
10 |
8 |
6 |
0 |
14 |
14 |
10 |
10 |
8 |
4 |
0 |
Total Score |
19 |
31 |
25 |
18 |
6 |
0 |
19 |
24 |
20 |
15 |
8 |
4 |
0 |
Key: hr = hour(s) IPR = initial pain reaction
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material was determined to be irritating to the eye based on iritis, conjunctival redness and chemosis.
- Executive summary:
An in vivo study was performed under GLP conditions to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with OECD Guideline 405 and EU Test Method B.5.
A single application of the test item to the non-irrigated eye of two rabbits produced scattered or diffuse corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. One treated eye appeared normal at the 14-Day observation and the other treated eye appeared normal at the 21-Day observation.
Under the conditions of the test, the test material was determined to be irritating to the eye based on iritis, conjunctival redness and chemosis.
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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