Fatty acids, C16-18 and C18-unsatd., Me esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1984-03-26 To 1984-07-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a: The study was performed according to OECD guideline 404 and GLP.

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., Me esters

EC Number:

267-015-4

EC Name:

Fatty acids, C16-18 and C18-unsatd., Me esters

Cas Number:

67762-38-3

Molecular formula:

UVCB substance, not univocal molecular formula available

IUPAC Name:

UVCB substance, no IUPAC name avalilable Chemical name: C16-C18 and C18 unsaturated alkyl carboxylic acids methyl esters

Details on test material:

- Name of test material : Metiloil A
- Physical state: yellow liquid
- Storage condition of test material: at room temperature
- Composition of test material, percentage of components: mixture of methylesthers of satured and insatured C16to 18 fatty acids, no data
- Lot/batch No.: 1169
- Acid number: 7 mgKOH/g

Test animals

Species:

rabbit

Strain:

other: New Zealand White: Hy/Cr

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Age at study initiation: no data
- Weight at study initiation: 2.35 kg +/- 0.05 kg
- Housing: individually in polystyrene cage (35 x 55 x 32 cm).
- Diet: rabbit diet SQC (Special diets Services Ltd, Witham, Essex, England), ad libitum
- Water: filtered water with 0.22 µm Millipore membrane (Millipore, 67120 Molsheim, France), ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 50 % +/- 20 %
- Air changes (per hr): no data (filtered Air)
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 1984-05-18 To: 1984-05-21

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left flank

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: right flank (6 cm2)
- % coverage: no data
- Type of wrap if used: A gauze pad was applied on the tested area and was held in contact with the skin by means of an adhesive hypoallergenic
semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE: No

SCORING SYSTEM: according to the grading of skin reactions described in OECD guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

> 0 - < 0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight erythema was observed in all animals after one hour exposure and disappeared completely after 3 days. No edema was reported.
See table 1 in field "Remarks on results including tables and figures".

Other effects:

No other local or systemic effects were observed.

Any other information on results incl. tables

Table1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point/ Reversibility	Erythema Max. score: 4	Edema Max. score: 4
60 min	2/2/2/2/2/2	0/0/0/0/0/0
24 h	0/1/0/1/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0.33/0/0	0
Reversibility*)	c.	-

*) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible

Grading of skin reactions:

Erythema and Eschar Formation

0 = No erythema

1 = Very slight erythema (barely perceptible)

2 = Well defined erythema

3 = Moderate to severe erythema

4 = Severe erythema (beef redness) to eschar formation preventing grading of erythema

Edema Formation

0 = No edema

1 = Very slight edema (barely perceptible)

2 = Slight edema (edges of area well defined by definite raising)

3 = Moderate edema (raised approximately 1 mm)

4 = Severe edema (raised more than 1 mm and extending beyond area of exposure)

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Conclusions:

Metiloil A was not considered to be a skin irritant.

Executive summary:

In a primary dermal irritation study (Kaysen A., 1984), young adult New Zealand White rabbits (6 males) were exposed by dermal contact to 0.5 ml of Metiloil A (batch No. 1169) onto one flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 3 days. Irritation was scored by the grading of skin reactions described in the OECD guideline 404. Slight erythema was observed in all animals after one hour exposure and disappeared completely after 3 days. No edema was observed. Mean scores over 1, 24, 48 and 72 hours were 2, 0.33, 0 and 0 for erythema and 0, 0, 0 and 0 for edema, respectivelly.

In this study, metiloil A is slightly irritating when applied topically to rabbit skin, but not classified according to the EU-GHS criteria.