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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 September - 04 October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted and well described study in accordance with GLP and OECD guideline 402 without any deviation

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:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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: 94.2 %
- Lot/batch No.: AY02/111
- Date of receipt: 07 September 2006
- Expiration date of the lot/batch: July 2007
- Storage condition of test material: Stored at +4 °C and protected from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: Males: 323 ± 9 g; females: 218 ± 8 g
- Housing: Animals were housed in polycarbonate cages with stainless steel lid. Each cage contained 1-7 rats/sex during the acclimation period and 1 rat/cage during the treatment period.
- Diet: SsniffR/M-H pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal area, approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females
- % coverage: Approximately 10 % of the total body surface area
- Test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied on the clipped skin.
- Test item and the gauze pad were held in contact with the skin for 24 h by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test item by the animals.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test item was removed using a moistened cotton pad.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: Yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until Day 15. From Day 2, any local cutaneous reaction was recorded.
Bodyweight was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: Yes;, all animals were killed by carbon dioxide asphyxiation on Day 15 and all animals were subjected to a macroscopic examination.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no clinical signs, cutaneous reactions or mortality were observed.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs and no cutaneous reactions were observed.

Gross pathology:

- No macroscopic abnormalities were observed at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of Mexoryl SBF is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, a group of Sprague Dawley [Rj: SD (IOPS Han)] rats (5/sex/dose) were given a single dermal application of Mexoryl SBF at 2000 mg/kg bw. Test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied to an area of the skin (approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females) representing approximately 10% of the total body surface of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No deaths, no clinical signs and no cutaneous reactions were observed during the study. When compared to historical control animals, a slightly lower body weight gain was noted in 1/5 females between Day 1 and Day 8 and in another female between Day 8 and Day15, without any relevant consequence at the end of the observation period. Overall body weight gain of the other animals was similar to that of historical control animals. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 of Mexoryl SBF was considered to be higher than 2000 mg/kg bw in rats.

The acute dermal LD50 of Mexoryl SBF is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).