Fatty acids, C16-18, 2-ethylhexyl 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:

key study

Study period:

May 09th, 1990 - May 12th, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Analytical purity of test material not specified.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl palmitate

EC Number:

249-862-1

EC Name:

2-ethylhexyl palmitate

Cas Number:

29806-73-3

Molecular formula:

C24H48O2

IUPAC Name:

2-ethylhexyl palmitate

Details on test material:

- Name of test material (as cited in study report): 2-ethylhexyl palmitate
- Physical state: colorless liquid
- Lot/batch No.: 950
- Storage condition of test material: RT
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.34 - 2.59 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum, (Rabbit diet, Preston Farmers Limited, UK)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 65 - 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites served as controls

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Gauze patch secured with surgical adhesive tape and wrapped with an elastic corset (TUBIGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cottonwool soaked with diethyl ether
- Time after start of exposure: 4 h


SCORING SYSTEM: According to Draize (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 11, mean of readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal: 24, mean of readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal: 70, mean of readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all three animals and of readings at

Time point:

other: 24 h, 48 h and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

Erythema Score

Animal Number	24 h	48 h	72 h	Total	Mean
11	1	1	0	2	0.7
24	1	0	0	1	0.3
70	1	1	0	2	0.7

 

Edema Score

Animal Number	24 h	48 h	72 h	Total	Mean
11	1	0	0	1	0.3
24	1	0	0	1	0.3
70	1	0	0	1	0.3

 

Primary Irritation Index:

Sum of 24 h and 72 h readings: 3

Primary Irritation Index: 3/6 = 0.5

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU