Fatty acids, C8-10, 3-methylbutyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (test substance purity not specified; no reading at 48 hours; observation time only 72 hours).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

test substance purity not specified; no reading at 48 hours; observation time only 72 hours

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Hexyl laurate

EC Number:

251-932-1

EC Name:

Hexyl laurate

Cas Number:

34316-64-8

Molecular formula:

C18H36O2

IUPAC Name:

hexyl laurate

Test animals

Species:

rabbit

Strain:

other: New Zealand males

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

Duration of treatment / exposure:

24 hours

Observation period:

72 hours
- Reading time points: 24 and 72 hours

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

Time point:

24/48/72 h

Score:

1.34

Max. score:

4

Reversibility:

not 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

Time point:

24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

not 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

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	1	0	2	1	2	0	1	0	1	0	2	0
48 h^1	1	0	2	1	2	0	1	0	1	0	2	0
72 h	1	0	1	0	1	0	0	0	1	0	2	1
Mean value 24 +48 + 72 h	1.00	0.00	1.67	0.67	1.67	0.00	0.67	0.00	1.00	0.00	2.00	0.33

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	2	1	2	0	1	0	1	0	2	0
48 h^1	2	0	2	1	2	0	1	0	1	0	2	0
72 h	1	0	1	0	0	0	0	0	1	0	2	1
Mean value 24 +48 + 72 h	1.67	0.00	1.67	0.67	1.33	0.00	0.67	0.00	1.00	0.00	2.00	0.33

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

¹ 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

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