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Diss Factsheets
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EC number: 700-161-3 | 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
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Methods for the Determination of Toxicity Method B.5 Directive 92/69/EEC
- 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: Not reported
- Weight at study initiation: 2402, 2734 & 2657 g
- Housing: Singly in stainless steel, wire-mesh cages suspended above cage boards. Enrichment (e.g., toy) was placed in each cage
- Diet (e.g. ad libitum): Approximately 125 grams of Rabbit LabDiet® 5322 daily during the study
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22ºC
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): approximate 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):
- Approximately 30 to 60 seconds after exposure; then approximately 1, 24, 48, and 72 hours after treatment. One rabbit was further examined 7 and 14 days 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: Illumination and magnification, and fluorescein stain (24-hour and each subsequent evaluation).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: range
- Time point:
- other: 1 hour to 14 days
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: range
- Time point:
- other: 1 hour to 14 days
- Score:
- 0 - 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- other: range
- Time point:
- other: 1 hour to 14 days
- Score:
- 1 - 2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Conjunctival redness (score of 1 or 2), conjunctival chemosis (score of 1), and discharge (score of 1 or 2) were observed in the treated eye of all 3 rabbits. Additionally, iritis (score of 1) was observed in the treated eye of 2 rabbits. Fluorescein stain examinations were negative for corneal injury in the treated eye of all rabbits. The treated eye of the rabbits was normal by 24 hours, 48 hours, or 14 days after instillation of the test substance.
The ocular scores from individual animals with respect to observation time are presented in Table 1. Mean ocular scores calculated in accordance with EEC/GHS are presented in Table 2. - Other effects:
- Two of the 3 rabbits pawed the treated eye after instillation of the test substance. One rabbit exhibited hair loss around the eye at 7 days. No clinical signs of systemic toxicity were observed and no body weight loss occurred.
Any other information on results incl. tables
Table 1 |
||||||||
Individual Rabbit Ocular Irritation Scores Following Treatment with Test Substance |
||||||||
Reading |
Rabbit Number |
Cornea |
Iritis |
Conjunctiva |
Fluorescein Stain |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
||||
1 Hour |
341a 370 372 |
0 0 0 |
0 0 0 |
1 0 1 |
1 1 1 |
1 1 1 |
2 2 2 |
NA NA NA |
24 Hours |
341 370 372 |
0 0 0 |
0 0 0 |
0 0 0 |
0 1 2 |
0 0 1 |
0 2 2 |
NEG NEG NEG |
48 Hours |
341 370 372 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 1 |
0 0 1 |
0 0 1 |
NEG NEG NEG |
72 Hours |
341 370 372 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 1 |
0 0 1 |
0 0 0 |
NEG NEG NEG |
7 Days |
341 370 372 |
-- -- 0 |
-- -- 0 |
-- -- 0 |
-- -- 1 |
-- -- 0 |
-- -- 1 |
NA NA NEG |
14 Days |
341 370 372 |
-- -- 0 |
-- -- 0 |
-- -- 0 |
-- -- 0 |
-- -- 0 |
-- -- 0 |
NA NA NEG |
NA = Not Applicable NEG = Negative for corneal injury -- = Not evaluated since all ocular irritation cleared prior to this timepoint a = Initial rabbit tested |
Table 2 |
||||
Mean Scoresa for Ocular Responses for Individual Rabbits |
||||
Rabbit Number |
Corneal Opacity |
Iritis |
Conjunctival Redness |
Conjunctival Chemosis |
341 370 372 |
0 0 0 |
0 0 0 |
0 0.33 1.33 |
0 0 1.0 |
a 24hr + 48 Hr + 72hr/3. Calculated according to EEC/GHS. |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance produced slight iritis and conjunctivitis when instilled into the rabbit eye. All irritation cleared by 14 days.
- Executive summary:
The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. Two of the 3 rabbits pawed the treated eye after instillation of the test substance. Conjunctival redness (score of 1 or 2), conjunctival chemosis (score of 1), and discharge (score of 1 or 2) were observed in the treated eye of all 3 rabbits. Additionally, iritis (score of 1) was observed in the treated eye of 2 rabbits. Fluorescein stain examinations were negative for corneal injury in the treated eye of all rabbits. The treated eye of the rabbits was normal by 24 hours, 48 hours, or 14 days after instillation of the test substance. No clinical signs of systemic toxicity were observed, and no body weight loss occurred. One rabbit exhibited hair loss around the eye at 7 days. Under the conditions of this study, the test substance produced slight iritis and conjunctivitis when instilled into the rabbit eye. All irritation cleared by 14 days.
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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