Fatty acids, coco, esters with oxybis(propanediol)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to internationally accepted testing guideline, well documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

Octanoic acid, monoester with glycerol

EC Number:

247-668-1

EC Name:

Octanoic acid, monoester with glycerol

Cas Number:

26402-26-6

Molecular formula:

C11H22O4

IUPAC Name:

octanoic acid, monoester with glycerol

Test material form:

other: waxy

Details on test material:

- Name of test material: Imwitor 308
- Substance type: Product
- Physical state: white waxy solid
- Lot/batch No.: Chg 013
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: yes
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.40 - 2.52 kg
- Housing: single housing in suspended metal cages
- Diet (e.g. ad libitum): free access to Rabbit Diet, supplied by Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): free access to mains drinking water throughout the study
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13 - 22
- Humidity (%): 55 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Arachis oil B.P.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): For the purpose of this study the test material was freshly prepared at a concentration of 20% w/w in arachis oil. The test material preparation was warmed to aid solubilisation.

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

2 females, 1 male

Details on study design:

TEST SITE
- Area of exposure: clipped skin on the dorsal/flank area, intact epidemis
- % coverage: not mentioned
- Type of wrap if used: On the application area a gauze patch (2.5 cm x 2.5 cm) was placed. The patch was secured in position by a strip of surgical adhesive tape (BLENDERM: approx. size 2.5 cm x 4.0 cm). The trunk of the animals was wrapped in an elasticated corset (TUGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.5

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0.56
- Edema: 0

Other effects:

Desquamation was commonly noted during the study.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 2	Max. score: 1
60 min	1/1/1	0/0/0
24 h	1/0/1	0/0/0
48 h	1D/0D/1	0/0/0
72 h	0D/0D/1D	0/0/0
Average 24h, 48h, 72h	0.56	0
Reversibility*)	c.	c.
Average time (unit) for reversion	7 days	not relevant

 

*) Reversibility: c. = completely reversible; D = desquamation

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

The test material, octanoic acid, monoester with glycerol (20% in arachis oil S.P.), was found to be a mild irritant to rabbit skin. No corrosive effects were noted.