Oligo

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 - 22 May 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

no rationale for in vivo testing, no initial testing (at first only one animal)

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids C16-18 (even numbered), oligoesters with sucrose

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Fatty acids C16-18 (even numbered), oligoesters with sucrose

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

albino rabbit, Chbb: NZW (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, Biberach, Germany
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: commercial diet (ssniff K-H (V2333)), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 - 10 May 1996

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

about 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 square cm.

Vehicle:

other: Polyethylenglycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g, pasted with 0.5 ml Polyethylenglycol 400

Duration of treatment / exposure:

4 hours

Observation period:

30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal region
The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

OBSERVATION TIME POINTS
30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

No signs of irritation were observed during the whole study.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.