Saccharomyces cerevisiae cell wall, extracted

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 09 June 2011 to 19 December 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Saccharomyces cerevisiae cell wall, extracted

EC Number:

949-711-6

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Saccharomyces cerevisiae cell wall, extracted

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste­ F40260 Linxe)
- Age at study initiation: 13 weeks old
- Weight at study initiation: 2.45 - 3.10 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet (e.g. ad libitum): foodstuff (SDS - C15) ad libitum
- Water (e.g. ad libitum): tap-water from public distribution system ad libitum
Microbiological and chemical analyses of the water were carried out once evety six months by IPL, Sante, Environnement Durables - Atlantique
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 (continuous light (07.00 to 19.00))

IN-LIFE DATES: not specified.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: on the opposite flank an untreated area served as the control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable

Duration of treatment / exposure:

4h (as no tissue destruction was noted after a treatment during 3 minutes and 1 hour, the test item was applied, during 4 h).

Observation period:

1 h and then 24, 48 and 72 h after removal of the patch and up to 14 days if necessary (if no reaction is observed 72 h after the treatment, the study is terminated. In case of persistent reactions, additional observations can be carried out from day 4 to day 14 in order to determine the reversible character of the lesions observed).

Number of animals:

3 male rabbits (initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal on day 3, two additional animals were treated during 4 h).

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: not specified
- Type of wrap if used: the treated area is covered with a gauze patch, which is maintained in position by a semi occlusive dressing. The dressing is covered with an elastic strap taped in place around the animal's body, taking care not to impede its respiratory and abdominal movements.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; after the removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: after the removal of the patch (4h post treatment).

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1 h and then 24, 48 and 72 h after removal of the patch.

SCORING SYSTEM:
- Method of calculation: 1h then 24, 48 and 72 h after patch removal the animals underwent a macroscopic skin examination, on each occasion under the same conditions (in particular with regard to ambient lighting). This examination consisted in assessing the irritant reactions in the treated zone, compared to a control area. The following scales are used:

Erythema and Eschar formation
0 ...... No etythema
I ...... Very slight Eythcma (barely perceptible)
2 ...... Well defined erythema
3 ...... Moderate to severe erythema
4 ...... Severe erythema (beef redness) with eschars formation preventing grading of erythema

Oedema
0 .......No oedema
I..........Very slight oedema (barely perceptible)
2 ....... Slight oedema (contour clearly defined)
3 ....... Moderate oedema (raised approx. 1 mm)
4 ....... Severe oedema (raised more than 1 mm, and extending beyond area of exposure)

EXAMINATION OF THE GENERAL CONDITION OF THE ANIMALS
The systemic toxicity, expressing by behavioral abnormalities, alteration of neuro-vegetative reactions or decrease feeding, and any toxic effects are to be logged and described. The animals are weighed at the start and at the end of the test.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

edema score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

No skin reaction was recorded in any animal 1h after the patch removal.
A slight erythema was noted on the treated area of one animal, 24 h after the patch removal. The reaction was totally reversible at the reading time 48 hours.

Other effects:

- Other adverse local effects: none.
- Other adverse systemic effects: none.

Any other information on results incl. tables

Animal weight evolution:

Animal #	Weight at start of experiment (kg)	Weight at end of experiment (kg)
1	2.45	2.55
2	2.93	3.10
3	2.89	3.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the test item Saccharomyces cerevisiae cell wall, extracted was not irritating to the rabbit skin. Thus, the test material is not classified for skin irritation / corrosion according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria and the UN-GSH system.

Executive summary:

This GLP-compliant study was performed to assess the potential of Saccharomyces cerevisiae cell wall, extracted to induce skin irritation in vivo, according to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and EU method B.4 (EU Acute Toxicity: Dermal Irritation / Corrosion).

Material and methods

0.5 g of test item was applied to the skin of three New Zealand White rabbits. The test item was applied as a single dose. Sufficient water was used to dampen the test material to ensure good contact with the skin. The treated area is covered with a  gauze patch, which is maintained in  position by a semi occlusive dressing. The dressing is covered with an elastic strap taped in place around the animal's body, taking care not to impede its respiratory and abdominal movements. Each rabbit is its own control, i.e untreated skin areas of the test animal serve as the control. After 4h, the remaining test item was removed with distilled water.

Systemic toxicity, expressing by behavioral abnormalities, alteration of neuro-vegetative reactions or decrease feeding, and any toxic effects were logged and described. The animals are weighed at the start and at the end of the test. The irritancy of the test item was evaluated according to the Draize method. Animals were examined at 1, 24, 48, and 72 hours after the patch removal.

Results

There was no mortality during the observation period and no test item related effect on body weight.

No skin reaction was recorded in any animal 1h after the patch removal.

A slight erythema was noted on the treated area of one animal, 24 h after the patch removal. The reaction was totally reversible at the reading time 48 hours.

The animals’ individual mean scores (24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.33 respectively.

The animals’ individual mean scores (24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.

Conclusion

Under the experimental conditions of this study, the test item Saccharomyces cerevisiae cell wall, extracted was not irritating to the rabbit skin. Thus, the test material is not classified for skin irritation / corrosion according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria and the UN-GSH system.