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EC number: 481-870-2 | 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:
- 10 April 2007 and 19 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: New Zealand White rabbits were supplied by an accredited supplier.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: Weight range of 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet.
- Water (e.g. ad libitum): Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study.
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): The lighting was 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:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A volume of 0.1 ml of the test material, which was found to weigh approximately 66 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye.
- Concentration (if solution): Not available
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:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Any other ocular effects were also noted
Interpretation of Results:
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal 66163
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal 66172
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal 66173
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 66163
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 66172
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 66173
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 66163
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effect noted
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 66172
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effect noted
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 66173
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 66163
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 66172
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 66173
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect noted
- Irritant / corrosive response data:
- No corneal or iridial effects were noted.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24-hour observation.
All treated eyes appeared normal at the 48-hour observation. - Other effects:
- Purple/pink-coloured staining of the fur was noted around all treated eyes throughout the study.
Any other information on results incl. tables
Individual scores for ocular irritation are given in Table1.
Table1 IndividualScores and Individual Total Scoresfor Ocular Irritation
Rabbit Number and Sex |
66163 Male |
66172 Male |
66173 Male |
|||||||||
IPR= 2 |
IPR = 2 |
IPR = 2 |
||||||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
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 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
|
|
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
|
|
|
A = Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B = Chemosis |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
C = Discharge |
2Sf |
1Sf |
0Sf |
0Sf |
1Sf |
1Sf |
0Sf |
0Sf |
1Sf |
0Sf |
0Sf |
0Sf |
Score (A + B + C) x 2 |
10 |
6 |
0 |
0 |
8 |
6 |
0 |
0 |
8 |
4 |
0 |
0 |
Total Score |
10 |
6 |
0 |
0 |
8 |
6 |
0 |
0 |
8 |
4 |
0 |
0 |
IPR= Initial pain reaction
Sf= Purple/pink-coloured staining of the fur around the treated eye
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (based on the mean scores for each animal).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
- Executive summary:
- The study was performed to assess the irritancy potential of the
test material to the eye of the New Zealand White rabbit. The method was
designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)
§ Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC
A single application of the test material was applied to the non-irrigated eye of three rabbits. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
No corneal or iridial effects were noted.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24-hour observation.
All treated eyes appeared normal at the 48-hour observation.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
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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