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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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: protocol complies with scientifically accepted methods, and is sufficiently detailed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- no
Test material
- Details on test material:
- - Physical state: Pale amber colored liquid
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratories, Inc. Denver, PA. USA.
- Age at study initiation: approximately 14 weeks of age.
- Weight at study initiation: average for male was 2433 g, average for female was 2412g.
- Housing: animals were maintained individually in screen bottom cages in temperature and humidity controlled quarters.
- Diet (e.g. ad libitum): No data available.
ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled environment, but no temperature provided.
-Humidity (%):controlled environment, but no humidity information provided.
-Air changes: controlled environment, but no air change information provided.
-Photoperiod: controlled environment, but no photoperiod information provided.
IN-LIFE DATES: From: 04/09/1980 To: 04/20/1980.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 7 days under laboratory conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted.
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable.
- Concentration (if solution): Not applicable.
- Lot/batch no. (if required): Not applicable.
- Purity: Not applicable. - Duration of treatment / exposure:
- The test material was not washed, so animal exposure to test material for the entire test period.
- Observation period (in vivo):
- The treated eyes were observed at 24, 48, 72 and 96 hour after treatment.
- Number of animals or in vitro replicates:
- 3 male and 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None.
- Time after start of exposure: Not applicable.
SCORING SYSTEM: Draize score system.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.167
- Max. score:
- 4
- Reversibility:
- other: 72 hour score 0, 96 hour score 0.5.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- None
Any other information on results incl. tables
Table 1. Body Weight Data
|
Animal No. |
Initiation |
Terminal (day 7) |
Male |
1 |
2398 |
2527 |
2 |
2452 |
2592 |
|
3 |
2418 |
2511 |
|
Average |
2423 |
2543 |
|
Female |
4 |
2403 |
2482 |
5 |
2501 |
2409 |
|
6 |
2332 |
2333 |
|
Average |
2412 |
2408 |
Table 2. Individual Data for ocular Reactions
Sex |
Male |
Female |
|||||
Animal No. |
1 |
2 |
3 |
4 |
5 |
6 |
|
24 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0.5 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0.5 0 0 |
1.0 0 0 |
|
48 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0.5 0 0 |
0.5 0 0 |
|
72 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Sodium Fluorescein Examination |
-ve |
-ve |
-ve |
-ve |
-ve |
-ve |
|
96 h |
Cornea - Opacity - area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae - Redness - Chemosis - Discharge |
0 0.5 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Primary Eye irritation scores |
24 h: 0.7 48 h: 0.3 72 h: 0.3 96 h: 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: FHSA regulations
- Conclusions:
- Test eyes treated with the substance did not exhibit ocular effects at all time points observed throughout the study. Following assessment of the data for all endpoints, the test material is not a primary eye irritant
- Executive summary:
In a study to evaluate the ocular irritancy potential of the substance using New Zealand White strain rabbit. The substance did not cause any ocular effects therefore it is not a primary 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.
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