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EC number: 456-880-5 | CAS number: 439685-79-7
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Boiling point
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- Short-term toxicity to fish
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01-11 December 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study conducted in compliance with OECD Guideline 405 with deviations: one animal received 0.07 mL of the test item instead of 0.1 mL; temperature and relative humidity recorded sometimes outside of the target ranges; non-ocular local and systemic adverse effects not followed; individual animal weights not reported
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- one animal received 0.07 mL of the test item instead of 0.1 mL; temperature and relative humidity recorded sometimes outside of the target ranges; non-ocular local and systemic adverse effects not followed; individual animal weights not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material : Mexoryl SBF
- Physical state: Thick brownish paste (very sticky)
- Analytical purity: 92 %
- Lot/batch No.: 003D001
- Date of receipt: 18 November 2005
- Expiration date of the lot/batch: October 2006
- Storage condition of test material: Stored at +4 °C and protected from light
- pH of the test item at the concentration of 10 % in purified water, measured was approximately 6.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., Roussay, France.
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.8 ± 0.1 kg
- Housing: Animals were housed individually in Pajon cages.
- Diet: Control Reference 110 pelleted diet (SAFE, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test item - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to OECD Guideline 405
TOOL USED TO ASSESS SCORE:
- At 24 h after treatment, 0.5 % sodium fluorescein solution was instilled into the eyes and they were examined under UV-lamp to detect possible corneal damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- - Slight or moderate conjunctival reactions (slight or moderate chemosis, slight or moderate redness of the conjunctiva and clear discharge) were observed in all animals from Day 1 up to Day 3.
- No other ocular reactions were noted during the study. - Other effects:
- No data
Any other information on results incl. tables
Table 7.3.2/1: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 h)
Rabbit No. |
Region of eye |
Scores |
||||
1 h (Day 1) |
24 h (Day 2) |
48 h (Day 3) |
72 h (Day 4) |
Mean # |
||
747 |
Conjunctivae: Chemosis |
2 |
1 |
1 |
0 |
0.7 |
Conjunctivae: Redness |
2 |
1 |
1 |
0 |
0.7 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
|
748 |
Conjunctivae: Chemosis |
2 |
1 |
1 |
0 |
0.7 |
Conjunctivae: Redness |
2 |
2 |
1 |
0 |
1.0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
|
749* |
Conjunctivae: Chemosis |
2 |
1 |
1 |
0 |
0.7 |
Conjunctivae: Redness |
2 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
#: Mean of scores on Days 2, 3 and 4 *: animal 749 received only 0.07 mL of the test substance
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Mexoryl SBF is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item, Mexoryl SBF in their left eye while the right eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. At 24 h after treatment, 0.5 % sodium fluorescein solution was instilled into the eyes and they were examined under UV-lamp to detect possible corneal damage. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the method of OECD Guideline 405.
Slight or moderate conjunctival reactions (slight or moderate chemosis, slight or moderate redness of the conjunctiva and clear discharge) were observed in all animals from Day 1 up to Day 3. No other ocular reactions were recorded during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 1.0, 0 for redness of conjunctivae score and 0.7, 0.7, 0.7 for chemosis score. In this study, Mexoryl SBF is not an eye irritant on male rabbits.
Under the test conditions, Mexoryl SBF is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
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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