Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized, reaction products with ethylene glycol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998/06/03- 1998/07/04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1992)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane

EC Number:

606-155-6

Cas Number:

188831-96-1

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane

Specific details on test material used for the study:

- Name of test material: SAT 980403, Soj amethylesterepoxid TMP ring geöffnet, Sovermol 760
- Physical state: clear, colourless, viscous liquid
- Analytical purity: 90 %
- Expiry date: Jan 1999
- Lot/batch No.: 18009
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: E.A. Prinzhom, Altenbücker Damm 28, 27333 Altenbücken, Germany
- Weight at study initiation: > 2.5 kg
- Housing: The rabbits were kept individually in a battery of cages with a cage size of 50 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet: "Harlan Teklad TLM Rabbit Maintenance Diet" pelleted breeding diet produced by Harlan Teklad, Shaw's farm, Blackthom Bicester, Oxon, OX6 OTP, England
- Water: community tap water
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30- 70 %
- Air changes: 16/ hour
- Photoperiod: cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted

Duration of treatment / exposure:

4 hours

Observation period:

Skin reactions were assessed 1, 24, 48 and 72 h after the end of the exposure.

Number of animals:

2 males
1 female

Details on study design:

TEST SITE
- Type of wrap if used: semiocclusive bandage, Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), nonirritating tape Elastoplast® (Beiersdorf AG, Hamburg) and Stülpa® (P. Hartmann AG, Heidenheim-Brenz), which enveloped the whole ofthe animal's trunk.

SCORING SYSTEM:
Skin reactions were graded based on the calculated mean values as stipulated by OECD 404:

Erythema and Eschar Formation
0 Non erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to eschar formation preventing grading of erythema

Oedema Formation
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Irritant / corrosive response data:

Mean values of skin reactions at 24, 48 and 72 h after exposure (test side)
animal 1: 1.67 (erythema); 0.67 (oedema)
animal 2: 2.00 (erythema); 0.67 (oedema)
animal 3: 1.33 (erythema); 0.67 (oedema)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met