Ethyl 3,5,5-trimethylhexanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

August 1994 to December 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31, 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

July 17, 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 3,5,5-trimethylhexanoate

EC Number:

266-959-4

EC Name:

Ethyl 3,5,5-trimethylhexanoate

Cas Number:

67707-75-9

Molecular formula:

C11H22O2

IUPAC Name:

ethyl 3,5,5-trimethylhexanoate

Details on test material:

- Name of test material: 3,5,5-Trimethyl-ethyl capronate
- Physical state: colorless liquid
- Analytical purity: >90%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97633 Sulzfeld
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum
- Water (e.g. ad libitum): tap water from an automatical watering system, ad libitum
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 (average)
- Humidity (%): 50 (average)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated control areas on each animal

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

6 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on dorsal area of the trunk
- Type of wrap if used: cellulose patch with test substance was applied to the test site and held in place by fixing marginally with non irritating tape (Blendern Wundpflaster, 3M). The application site was covered by a dressing (Fixomull Stretch, Fa. Beiersdorf). Access by the animal to the application site was prevented by a plastic collar.

REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period the dressing, the tape with the patch and the collar were removed. Residual test substance was wiped off using wet cellulose tissue.

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 d

Results 4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

1/3 animals showed slight edema (grade 2) after 1 h, which was not present any more at the 24 h observation. The same animal showed very slight erythema (grade 1) at the 1, 24, 48 and 72 h observation. An additional examination at day 6 showed full reversibility.

Other effects:

no general toxic effects were noted

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	0/0/1	0/0/2
24 h	0/0/1	0/0/0
48 h	0/0/1	0/0/0
72 h	0/0/1	0/0/0
Average 24h, 48h, 72h	0/0/1	0/0/0
6 d	-/-/0	-/-/0

-      = no further examinations

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study 3,5,5-Trimethyl-ethyl capronate shows a very low irritant potential to the Skin and can be regarded as not classified for Skin Irritation according to GHS criteria

Executive summary:

In a primary dermal irritation study according to OECD guideline 404 (July 17, 1992) and EU method B.4 (July 31, 1992) 3 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted 3,5,5-Trimethyl-ethyl capronate (>90% a.i.) for 4 hours to 6 cm² body surface area. Animals then were observed for 6 days.  Irritation was scored by the method of Draize.

1/3 animals showed slight edema (grade 2) after 1 h, which was not present any more at the 24 h observation. The same animal showed very slight erythema (grade 1) at the 1, 24, 48 and 72 h observation. An additional examination at day 6 showed full reversibility.

Mean erythema scores from observations at 24, 48 and 72 h after patch removal were 0/0/0; mean edema scores were 0/0/1 for all three animals.

In this study, 3,5,5-Trimethyl-ethyl capronate was practically not irritating to rabbit skin.