L-gluco-Octitol, 1,5-anhydro-6,8-dideoxy-, (7.xi.)-

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

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

Test material information

Constituent 1

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.

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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).