Fatty acids, C8-12, isopentyl 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:

weight of evidence

Study period:

17 - 24 Jun 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, tested with the source substance Isopropyl myristate (CAS No. 110-27-0). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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)

Version / remarks:

adopted in 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl myristate

EC Number:

203-751-4

EC Name:

Isopropyl myristate

Cas Number:

110-27-0

Molecular formula:

C17H34O2

IUPAC Name:

isopropyl myristate

Details on test material:

- Name of test material (as cited in study report): isopropyl myristate
- Physical state: colourless liquid
- Analytical purity: approx. 100%
- Storage condition of test material: RT in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: female
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: approx. 2826 to 3238 g
- Diet: 100 g/day (Standard laboratory animal diet LK-01, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands)
- Water: tap water, ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 23
- Humidity (%): 60 - 85
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days
Reading time points: 1h, 24h, 48h, 72h and 7d

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: air- and vapor permeable gauze-patch fixed with a flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, using a tissue moistened with tap-water

SCORING SYSTEM: According to the criteria for irritancy and corrosiveness on the skin, Off. J. Europ. Commun., L 180/56 (91/325/EEC) (Draize)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

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 72h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The test substance caused very slight erythema disappearing completely within 7 days. Only one animal had slight edema up to 48 h after application.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time	Rabbit no.
	480		481		487
	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	1	1	1	1	1	1
48 h	1	1	1	1	1	1
72 h	1	0	1	0	1	0
7 d	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	1.00	0.67	1.00	0.67	1.00	0.67

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