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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 November - 02 December 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD guideline 404 with minor deviations: temperature and relative humidity in the animal room sometimes outside the target ranges; systemic 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

temperature and relative humidity in the animal room sometimes outside the target ranges; systemic 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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: 2.6 ± 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: 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

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (weight with unit): 500 mg

Duration of treatment / exposure:

- First animal: 3 minutes, 1 and 4 h
- Other two animals: 4 h

Observation period:

72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Anterior right flank (application for 1 h), anterior left flank (application for 3 minutes) and posterior right flank (application for 4 h).
- Type of wrap if used: Test item in its original form were placed on a gauze pad moistened with purified water and applied to an area of approximately 6 cm2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 h) or the posterior right flank (application for 4 h) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
- Untreated skin served as control.

REMOVAL OF TEST SUBSTANCE
- After removal of the dressing, any residual test item was wiped off by means of a moistened cotton pad.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema 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:

edema 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 3

Irritation parameter:

erythema 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 4

Irritation parameter:

edema 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 5

Irritation parameter:

erythema 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 6

Irritation parameter:

edema 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

Irritant / corrosive response data:

- After a 3-minute exposure (one animal), no cutaneous reactions were observed.
- After a 1-h exposure (one animal), no cutaneous reactions were observed.
- After a 4-h exposure (three animals), a very slight erythema (grade 1) was noted in 1/3 animals from Day 1 up to Day 3.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Individual skin reactions

Rabbits No.		Rabbit 747	Rabbit 748	Rabbit 749
Erythema	1 h	0	1	0
	24 h	0	1	0
	48 h	0	1	0
	72 h	0	0	0
Mean (24, 48 and 72 h)		0	0.7	0
Edema	1 h	0	0	0
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
Mean (24, 48 and 72 h)		0	0	0

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 skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).

Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 500 mg of Mexoryl SBF under a semi-occlusive dressing. The test item was first evaluated on a single animal and the duration of exposure was 3 minutes on the anterior left flank, 1 h on the anterior right flank and 4 h on the posterior right flank. Since the test item was not severely irritant on this first animal, it was then applied for 4 h to two other animals. After removal of the residual test item with moistened cotton pad, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h after exposure.

A very slight erythema was noted in 1/3 animals from Day 1 up to Day 3. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0.7, 0 for erythema and 0, 0, 0 for edema score, respectively. In this study, Mexoryl SBF is not a skin irritant on male rabbits.

Under the test conditions, Mexoryl SBF is not classified as irritating to skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).