Saccharides from Saccharomyces Cerevisiae

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Saccharides from Saccharomyces Cerevisiae

EC Number:

946-843-6

IUPAC Name:

Saccharides from Saccharomyces Cerevisiae

Test material form:

liquid

Details on test material:

yellow liquid

Test animals

Species:

rabbit

Strain:

other: New-Zealand

Details on test animals or test system and environmental conditions:

- Source: ESD 01400 ROMANS
- Weight at study initiation: about 2 to 2.5 kg at the time of trial
- Housing: Animals were kept in individual metal cages of standardized dimensions with perforated floor.
These cages are placed in a temperature controlled animal shelter where the temperature is between 18°C and 22°C and the relative humidity is maintained at between 30% and 80%. The air is filtered.
- Diet : Extralabo C15 ETS PIETREMENT
- Water (e.g. ad libitum): Tap filtered water provided ad libitum with automatic pipettes.
- Acclimation period: 5 days at least

Test system

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

the dressing is removed after 4 hours.

Observation period:

The irritation is measured 1 hour after removing the dressing, then the rating is repeated at hour 24
hours, 48 hours, 72 hours until day 7 if necessary.
If the irritation persists after day 7, the observations are extended until reversibility without exceeding a 14 day period.

Number of animals:

3 rabbits

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item can be rated as non irritant according to the protocol defined in the Official EEC Gazette of September 19, 1984.
In these conditions, the product does not provoke any specific irritant skin lesions.

Executive summary:

The test item was administered pure to 3 New Zealand rabbits at the dose of 0.5 ml. The experimental protocol was established according to the official in the Official EEC Gazette of September 19, 1984 and OECD guideline 404. The test item can be rated as non irritant.