Fatty acids, C8-10, C12-18-alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 - 18 Mar 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. The exposure was performed under occlusive conditions, the analytical purity of the test substance was not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive exposure

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C8-10, C12-18-alkyl esters

EC Number:

306-082-7

EC Name:

Fatty acids, C8-10, C12-18-alkyl esters

Cas Number:

95912-86-0

Molecular formula:

Unspecified

IUPAC Name:

Fatty acids, C8-10, C12-18 (even numbered)-alkyl esters

Details on test material:

- Name of test material (as cited in study report): coco caprylate/caprate
- Analytical purity: no data
- Physical state: clear liquid
- Lot/batch No.: 0907 D

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated skin site of the same animal served as the control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was not washed after patch removal

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibilty not applicable

Irritant / corrosive response data:

1 hour after exposure, all the animals had slight to well-defined erythema, while 2/3 had very slight to slight edema. These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. the edema persisted until the 48-hour reading time point.All skin irritation effects had cleared completely within 72 hours after the exposure ended.

Any other information on results incl. tables

Table 1: Erythema and edema scores for skin irritation of the individual animals at different reading time points:

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	2	1	0	1	1
24 h	1	2	0	0	0	0
48 h	0	1	0	0	0	0
72 h	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.33	1.00	0	0	0	0
Mean value 24 + 48 + 72 h all animals	0.11	0.33

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified