Fatty acids, C14-18 and C16-18-unsatd., maleated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, read across substance, according to GLP and OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1309959-24-7

Cas Number:

1309959-24-7

IUPAC Name:

1309959-24-7

Test material form:

liquid: viscous

Details on test material:

Physical state/ color: Liquid to high viscous / yellowish

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 5-6 month
- Weight at study initiation: 4.38 kg – 4.68 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml

Duration of treatment / exposure:

4h

Observation period:

Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.

Number of animals:

3 (2 females, 1 male)

Details on study design:

TEST SITE
- Area of exposure: flank

For better handling the test item was heated 1 hour at 70 °C. The test item was administrated lukewarm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4h

Illumination used for reading:
-Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)

Mortality:
-A check for any dead or moribund animal was made at least once each workday.

SCORING SYSTEM:

The evaluation of skin reactions was performed according to the quoted guidelines.

Erythema and eschar formation

Grading

0 No 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


Edema formation

Grading

0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well- defined by definite raising)
3 Moderate edema (raised approx. 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14d

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 14d

Irritant / corrosive response data:

Directly after removal of the patch well-defined erythema (grade 2) was noted in all animals, increased to moderate erythema (grade 3) and was observed until hour 72 in two animals until study day 7. Thereafter well-defined erythema was noted again in these two animals on study day 14. In the third animal very slight erythema (grade 1) was noted on study day 7 and increased to well-defined again on study day 14. Slight edema (grade 2) was noted in all animals immediately after removal of the patch, was noted in two animals again at the 1 hour-reading and increased to moderate edema (grade 3) at the 24-hours reading. In these two animals slight edema was noted at hour 48 and 72, again. In one of these animals moderate edema was noted on study day 7 and 14, while in the otheranimal very slight edema was noted on study day 14. In the third animal moderate erythema , observed 1 hour after application, increased to severe edema (grade 4) at hour 24, decreased to moderate edema at hour 48 and 72 and persisted as slight edema until study termination

Scaling was noted in two animals on study day 7 and 14, in the third animal on day 14 only. Additionally yellowish discoloration of the application site was observed in one animal at hour 48 and 72 and in another animal on study day 7.

The cutaneous reactions were not reversible in all animals within 14 days after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the described cutaneous reactions as well as the average score for irritation, the test item shows a skin irritating potential under the test conditions chosen