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Diss Factsheets
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EC number: 700-403-8 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- other: U.S. EPA Health Effects Test Guidelines OPPTS 870.2400
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Purity: not reported as such
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: Young adult
- Weight at study initiation: 2596, 2820, 2889 g
- Housing: Singly in suspended stainless steel caging with mesh floors. Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 or 26 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 63-71%. The humidity was above the targeted upper limit for one day during the study. A portable dehumidifier was used to decrease the humidity levels during this time.
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each rabbit was not treated with the test substance and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 1, 24, 48, and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated and control eyes of all rabbits remained unwashed.
SCORING SYSTEM: Draize Scale
TOOL USED TO ASSESS SCORE: High-intensity white light source and fluorescein stain (24-hour evaluation).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-, 48-, and 72-hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-, 48-, and 72-hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of the 24-, 48, and 72-hr scores for redness
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of the 24-, 48-, and 72-hr scores
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of the 24-, 48-, and 72-hr scores for redness
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of the 24-, 48-, and 72-hr scores
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of the 24-, 48-, and 72-hr scores for redness
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of the 24-, 48-, and 72-hr scores
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no corneal opacity or iritis observed in any treated eye during the study. One and 24 hours after test substance instillation, all treated eyes exhibited conjunctivitis. The treated eye of two rabbits was normal by 48 hours. Conjunctivitis was present in the treated eye of one rabbit at 48 hours. No ocular irritation was observed in the treated eye of this rabbit by 72 hours. Individual eye irritation scores are presented in Table 1. A summary of mean scores are presented in Table 2.
- Other effects:
- All animals appeared active and healthy during the study. No biologically significant weight loss occurred in any of the rabbits. Apart from the eye irritation, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.
Any other information on results incl. tables
Table 1 |
||||||||||||
Individual Scores for Ocular Irritation |
||||||||||||
|
Rabbit No. 3401 (Male) |
Rabbit No. 3402 (Female) |
Rabbit No. 3403 (Female) |
|||||||||
|
Hours |
|||||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
I. Cornea |
|
|||||||||||
A. Opacity |
0 |
01 |
0 |
0 |
0 |
01 |
0 |
0 |
0 |
01 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
II Iris |
|
|||||||||||
A. Values |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
III. Conjunctivae |
|
|||||||||||
A. Redness |
1 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
1 |
0 |
B. Chemosis |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
C.Discharge |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
12% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.
Table 2 |
||||
Mean Scores for Individual Rabbits |
||||
Rabbit Number |
Corneal Opacity |
Iritis |
Conjunctival Redness |
Conjunctival Chemosis |
3401 3402 3403 |
0.00 0.00 0.00 |
0.00 0.00 0.00 |
0.33 0.33 0.67 |
0.00 0.00 0.00 |
a Calculated from the 24-, 48-, and 72-hour scores. |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Irritation was observed in all treated eyes. The treated eye was normal in 2 rabbits by 48 hours and in 1 rabbit by 72 hours.
- Executive summary:
The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. There was no corneal opacity or iritis observed in any treated eye during the study. One and 24 hours after test substance instillation, all treated eyes exhibited conjunctivitis. The treated eye of two rabbits was normal by 48 hours. Conjunctivitis was present in the treated eye of one rabbit at 48 hours. No ocular irritation was observed in the treated eye of this rabbit by 72 hours.
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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