Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-05-08 to 1984-05-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD Guideline 1981

Deviations:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

IUPAC Name:

Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL: Hostacerin DGS
- lot/batch No.of test material: E06-400 282 (Date of production 1983-10-25),
- Physical state /colour: white flakes
- Purity test date: about 100 % Diglycerindistearat-Oxethylat, small amount of free stearic acid and polyglycerin

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 22 °C
- Stability under test conditions: n.a.
- Solubility of the test substance in the solvent/vehicle: soluble in warmed-up fat

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: soluble in warmed-up fat

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Hoe : HIMK (SPFWiga)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: n.a.
- Weight at study initiation: 2.6 to 4.1 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 diet - Rabbit, Altromin GmbH, Lage /Lippe
- Water (e.g. ad libitum): deionized, chlorianted water, automated watering place
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): n.a.
- Photoperiod (hrs dark / hrs light): 12 hrs

IN-LIFE DATES: From: 1984-05-08 To: 1984-05-15

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days after removal of plaster.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- % coverage:
- Type of wrap if used: semiocclusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): n.a.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 30 - 60 minutes, 24, 48, 72 hours and 7 days after removal of plaster.

SCORING SYSTEM:
- Method of calculation: numerical accrding to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

2

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

2

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

1

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

1

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

1

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

1

Results 7

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

1

Results 8

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

1

Results 9

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

1

Results 10

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the OECD 404 study, test substance is not irritating to the skin and thus not subject to labeling requirements.

Executive summary:

The test substance was tested for primary skin irritation according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL undiluted test substance warmed-up to 40°C. The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin. Examinations of skin took place after 30-60 minutes, 24, 48 and 72 hours after removal of the patches. Erythema and edema were evaluated numerically according to the score of Draize.

24 hours after removal of the patches two animals exhibited a well defined erythema (score 2), whereas the third animal showed slightly visible erythema (score 1). At 48 and 72 hours after removal of the patches all animals exhibited a slightly visible erythema (score 1). There were no edema observed at any time point at any animal (score 0). At 7 days after removal of patch all animals were free of skin reactions. A mean score of 1.2 for erythema and edema is determined.