Fatty acids, soya, iso-Pr esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 - 15 July 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl palmitate

EC Number:

205-571-1

EC Name:

Isopropyl palmitate

Cas Number:

142-91-6

Molecular formula:

C19H38O2

IUPAC Name:

isopropyl palmitate

Details on test material:

- Name of test material (as cited in study report): isopropyl palmitate
- Physical state: colourless liquid
- Analytical purity: approx. 100% ester
- Storage condition of test material: RT in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: Female
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: Mean 3446 g
- Diet: Standart laboratory animal diet LK-01
- Water: ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 65 - 85
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The test substance was applied to a gauze patch which was attached with a drop of petrolatum to aluminium foil and mounted on a permeable tape (Micropore, 3M, St. Paul, USA).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, using a tissue moistened with tap-water

SCORING SYSTEM: According to the criteria for irritancy and corrosiveness on the skin, Off. J. Europ. Commun., L 180/56 (91/325/EEC)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #3, respectively

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 14d

Results 3

Irritation parameter:

edema score

Basis:

animal: #1 and #3, respectively

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7d

Irritant / corrosive response data:

The dermal application of the test substance to rabbits caused very slight to well-defined erythema was completely reversible within 7 to 14 days.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	1	0	1	0	1	0
48 h	1	0	2	1	1	0
72 h	1	0	2	1	1	0
7 d	0	0	1	0	0	0
14 d	0	0	0	0	0	0
Mean value over 24 + 48 + 72 h	1.00	0.00	1.67	0.67	1.00	0.00

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: not classified