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Diss Factsheets
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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:
- 31 March to 10 April 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recently conducted GLP compliant study using the most recent test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan France SARL
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.9 to 4.24 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet)
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least five days each animal
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES: not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml of the test material (approx 77mg)
- Concentration (if solution): n/a
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: n/a
SCORING SYSTEM: Kay and Callandra; Kay J H and Calandra J C (1962), J. Soc. Cosmet. Chem. 13, 281-289
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 and 48 hr
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation. - Other effects:
- All animals showed expected gain in bodyweight during the study
Any other information on results incl. tables
Individual Scores and Individual Total Scores for Ocular Irritation |
Rabbit Number and Sex |
68319 Male |
68331 Male |
||||||
IPR = 2 |
IPR = 2 |
|||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
CORNEA |
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
A = Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B = Chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
C = Discharge |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
8 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
Total Score |
8 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
68319 Male |
8 |
2 |
0 |
0 |
68331 Male |
8 |
2 |
0 |
0 |
Group Total |
16 |
4 |
0 |
0 |
Group Mean Score |
8.0 |
2.0 |
0.0 |
0.0 |
Individual Bodyweights and Bodyweight Changes
Rabbit Number and Sex |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 3 |
||
68319 Male |
4.24 |
4.40 |
0.16 |
68331 Male |
2.90 |
3.01 |
0.11 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 8.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance is classified as NON-IRRITANT. No corrosive effects were noted.
- Executive summary:
The acute eye irritation has been assessed by means of exposure to rabbits according to EU method B5 in compliance with GLP. As no corrosivity or irritation were observed during the study, the substance is considered not irritating.
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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