Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given. Data on analytical purity, animal husbandry and the dose applied are missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

yes

Remarks:

data on analytical purity, animal husbandry and dose applied are missing

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decyl oleate

EC Number:

222-981-6

EC Name:

Decyl oleate

Cas Number:

3687-46-5

Molecular formula:

C28H54O2

IUPAC Name:

decyl octadec-9-enoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

other: untreated sites of the same animal served as control

Duration of treatment / exposure:

4 h

Observation period:

5 days
Reading time points: 1, 24, 48 and 72 h, and 5 days

Number of animals:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean after

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

5 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean after

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean after

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

5 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean after

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean after

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean after

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritant / corrosive response data:

3/3 animals had very slight erythema (grade 1) 1 hour after exposure ended. Very slight oedema (grade 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point, while 2/3 did not have edema at any reading time point. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well defined erythema. The erythema cleared in 1/3 animals within 48 hours and in the remaining 2 within 5 days. All irritation reactions were completely reversible within 5 days.

Any other information on results incl. tables

Table 1: Erythema and edema scores for the individual animals:

Animal No.	Reading time point	Erythema score	Edema score
1	1 h	1	0
	24 h	1	0
	48 h	1	0
	72 h	1	0
	5 d	0	0
2	1 h	1	0
	24 h	1	0
	48 h	0	0
	72 h	0	0
	5 d	0	0
3	1 h	1	1
	24 h	2	1
	48 h	1	1
	72 h	1	1
	5 d	0	0

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.