Fatty acids, C18 unsaturated, ethyl & methyl esters

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:

07 Apr - 29 Apr 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, tested with the source substance Methyl linoleate (CAS No. 112-63-0). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl linoleate

EC Number:

203-993-0

EC Name:

Methyl linoleate

Cas Number:

112-63-0

Molecular formula:

C19H34O2

IUPAC Name:

methyl octadeca-9,12-dienoate

Test animals

Species:

rabbit

Strain:

other: Kleinrussen, CHbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 15 months
- Weight at study initiation: approx. 2600 g
- Housing: individual accommodation
- Diet (e.g. ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, Soest/D, Batch: 770392/02, 550492/O9) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4h

Observation period:

1, 24, 48 and 72h; the observation period lasted 22 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal shaved skin, 6cm²
- Type of wrap if used: adhesive air- and vapour permeable gauze-patch which was fixed by a hypoallergenic adhesive gauze-bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the relevant skin was cleaned from the residual test substance
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: average 24, 48 and 72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 22 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: average 24, 48 and 72h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 22 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: average 24, 48 and 72h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: average 24, 48 and 72h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 22 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: average 24, 48 and 72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 22 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: average 24, 48 and 72h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

The irritation effects of one experimental animal reversed within 7 days. The skin of this rabbit showed eschar. The observed effects of the other two experimental animals reversed completely within 22 days.

Any other information on results incl. tables

Table 1: Individual irritation scores

Skin effect	Erythema					Edema
Scoring	Scores at				Mean	Scores at				Mean
Animal No.	1h	24h	48h	72h	24-72h	1h	24h	48h	72h
1266/1	1	2	2	2	2.00	0	2	1	1	1.33
1297/1	1	2	3	3	2.67	0	1	2	3	2.00
1300/1	1	1	1	1	1.00	1	1	2	1	1.33

Linolsäure Methylester has not to be classified according to CLP. According to DSD it has to be classified as:

Xi, R38: Irritating to skin

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
(DSD: Xi, R38: Irritating to skin)