Fatty acids, C18 (saturated and unsaturated) ethyl 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: The study was performed according to OECD guideline 404 and GLP. Test on read-cross substance used for this registration (CAS No 67762-38-3)

Justification for type of information:

This read-across is based on the hypothesis that source and target substances have similar toxicological properties. Both are UVCB substances being mixtures of fatty acid esters. Both are hydrolysed enzymatically to common products, i.e. the same fatty acids and to non-common products, i.e. methanol and ethanol in the case of the source substances respectively the target source. Methanol and ethanol have similar toxicological profiles. A read-across justification document is attached in section 13.

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)

Principles of method if other than guideline:

NA

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18 (saturated and unsaturated) ethyl esters

EC Number:

940-683-0

Cas Number:

1456887-14-1

Molecular formula:

UVCB substance molecular formula and weight not available. INCI: Shea Butter Ethyl esters

IUPAC Name:

Fatty acids, C18 (saturated and unsaturated) ethyl esters

Details on test material:

- Name of test material : Metiloil A (CAS No 67762-38-3)
- 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 vitro

Other effects / acceptance of results:

NA

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

> 0 - < 0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72h

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) (CAS No 67762-38-3) 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.