Fatty acids, C16-18 and C18-unsatd., Et esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

07 July - 10 July 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Lack of details on test substance; no reading at 48 hours; observation time only 72 hours.

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)

Deviations:

yes

Remarks:

lack of details on test substance; no reading at 48 hours; observation time only 72 hours

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl oleate

EC Number:

203-889-5

EC Name:

Ethyl oleate

Cas Number:

111-62-6

Molecular formula:

C20H38O2

IUPAC Name:

ethyl octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Lot/batch No.: 36

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and incised

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, 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
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 hours

Observation period:

72 hours
Reading time points: 24 and 72 h

Number of animals:

6 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals (since one animal died before the 72 h reading time point was reached, no scores for this animal and time point were given)

Time point:

other: mean over 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Since no reading was performed at 48 h, the score for this time point was assumed to be the same as the one observed at 24 h.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals (since one animal died before the 72 h reading time point was reached, no scores for this animal and time point were given)

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Since no reading was performed at 48 h, the score for this time point was assumed to be the same as the one observed at 24 h.

Irritant / corrosive response data:

At 24 hours, all 6 animals displayed erythema graded 1 to 2 on the intact skin; on the incised skin, erythema graded 1 to 2 was reported for 5 animals whereas the remaining one showed no erythema. No edema was seen.
At 72 hours, none of all 5 surviving animals displayed erythema or edema.

Other effects:

One animal died within 72 hours following treatment; mortality however was not related to treatment.

Any other information on results incl. tables

Table 1: Results of skin irritation study - intact skin

Observation time	Rabbit no.
	1*		2		3		4		5		6
	E	O	E	O	E	O	E	O	E	O	E	O
24 h	2	0	1	0	1	0	1	0	2	0	1	0
48 h^1	2	0	1	0	1	0	1	0	2	0	1	0
72 h	-	0	0	0	0	0	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	2.00	0.00	0.67	0.00	0.67	0.00	0.67	0.00	1.33	0.00	0.67	0.00

Table 2: Results of skin irritation study - incised skin

Observation time	Rabbit no.
	1*		2		3		4		5		6
	E	O	E	O	E	O	E	O	E	O	E	O
24 h	2	0	0	0	1	0	1	0	2	0	1	0
48 h^1	2	0	1	0	1	0	1	0	2	0	1	0
72 h	-	0	0	0	0	0	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	2.00	0.00	0.33	0.00	0.67	0.00	0.67	0.00	1.33	0.00	0.67	0.00

E: erythema, O: edema (according to Draize Score)

¹Since no reading was performed at 48 h, the score for this time point was assumed to be the same as the one observed at 24 h

^*Animal No. 1 died before the 72 hour reading time point was reached. Mean value for animal No. 1 was determined using 24 and 48 hour values. Death was not ascribable to the application of the test substance.

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