Isooctadecanoic acid, mixed esters with oxybis[propanediol]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

30 Oct. - 01 Nov. 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

only 72 h observation period

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Principles of method if other than guideline:

Modified Draize Testing method (Draize JH et al., J. Pharm. Exp. Ther. 82: 377-390, 1944; Draize JH, Assoc. Food Drugs Officials of the United States: 46-49, Topeka Kansas, 1965) as prescribed by the FDA (in The Federal Register 38 No.187 §15000.41, USA)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctadecanoic acid, ester with oxybis[propanediol]

EC Number:

277-361-8

EC Name:

Isooctadecanoic acid, ester with oxybis[propanediol]

Cas Number:

73296-86-3

Molecular formula:

C24H50O7

IUPAC Name:

16-methylheptadecanoic acid; 3-(2,3-dihydroxypropoxy)propane-1,2-diol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: approx. 3 months
- Weight at study initiation: approx. 2 kg
- Housing: individual in stainless steel cages
- Diet: 100 g/day/animal, Lab Diet Certified Rabbit Diet #5322
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): controlled, conditions not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: 30 October - 1 November 2001

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL corresponding to a thickness of approx. 0.5 mm on 2.5 x 2.5 cm2 test sites

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

2 males, 1 female

Details on study design:

TEST SITE
- Area of exposure: two test sites, each approx. 2.5 x 2.5 cm2 on opposite sides of the vertebral column in the mid-dorsal aera of the trunk
- Type of wrap if used: Square surgical gauze pads, 2.5 cm on each side, two single layers thick. The test article and gauze pad were covered with a piece of Kendall Webril pad and fixed in place with three inch hypo-allergenic cloth tape. The entire trunk of each animal was encased in an impermeable occlusive plastic wrapping, fixed in place with three inch porous tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by gently wiping with water and a paper towel
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS : 24, 48 and 72 h after dosing

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Both males (animal #1 and #2) exhibited the same irritation response. Moderate erythema (score 2) were observed for both animals at the 24 h reading. The erythema decreased to score 1 at the 48 and 72 h readings. The female (animal #3) showed moderate erythema formation (score 2) at all three readings. The effects were not fully reversible in the 72 h observation period of the study. With regard to edema formation, again for both males (animal #1 and #2) identical effects were observed. Only slight edema (score 1) were obvioius at the 24 h reading which were completely reversed at the 48 h after application. Animal #3 exhibited moderate edema formation (score 2) at the 24 h reading which was reduced to score 1 at the 48 h reading. 72 h after application, no edema was apparent in this animal anymore. No skin reactions other than erythema and edema were observed in any animal at any time.

No difference in erythema and edema formation between intact and abraded skin were observed in any animal at any time point, i.e. exact the same scores were recorded on the abraded test sites.

Any other information on results incl. tables

Table 1: Individual scores

		24 h		48 h		72 h
Rabbit	Skin	Erythema	Edema	Erythema	Edema	Erythema	Edema
1, m	Intact	2	1	1	0	1	0
	Abraded	2	1	1	0	1	0
2, m	Intact	2	1	1	0	1	0
	Abraded	2	1	1	0	1	0
3, f	Intact	2	2	2	1	2	0
	Abraded	2	2	2	1	2	0

Applicant's summary and conclusion

Interpretation of results:

other: not conclusive since study was terminated after 72 h

Conclusions:

A final conclusion on the hazard assessment and classification cannot be drawn as the study was terminated after 72 h and the effects observed were not fully reversible. It could well be that the effects observed would be not fully reversible within max. 21 days and, therefore, classification would be warrented even for the low individual scores.