Ethyl 3,5,5-trimethylhexanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

29.12.1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Feb. 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 (as cited in study report): 3,5,5-Trimethyl-ethyl-capronat
- Physical state: liquid
- Analytical purity: 95%

Test animals / tissue source

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Möllegaard Breeding and Research Centre Ltd., Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): pellets "Altromin 2123" from Altromin, ad libitum
- Water (e.g. ad libitum): tap water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: at least 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3
- Humidity (%): 55±15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

the eyes were rinsed after the 24 h observation

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after application the conjunctivae of all animals were injected (conjunctival redness, grade 1). Additionally 1/3 animals showed a slight swelling (chemosis, grade 1). Discharge (grade 1) was observed in all animals.
Conjunctival redness, grade 1 was present in 1/3 animals at the 24 h observation. The other two animals showed no reactions. No reactions of the eyes were observed in any of the animals 48 and 72 hours after application.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

In a primary eye irritation study according to OECD guideline 405 (Feb. 1987) and EU Method B.5 (29.12.1992) 0.1 mL of 3,5,5-Trimethyl-ethyl capronate (95% a.i.) was instilled into the conjunctival sac of the left eye of 3 young adult female Mol:Russian rabbits for 24 h (the eyes were rinsed after the 24 h observation). Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

One hour after application the conjunctivae of all animals were injected (conjunctival redness, grade 1). Additionally 1/3 animals showed a slight swelling (chemosis, grade 1). Discharge (grade 1) was observed in all animals.

Conjunctival redness, grade 1 was present in 1/3 animals at the 24 h observation. The other two animals showed no reactions.

No reactions of the eyes were observed in any of the animals 48 and 72 hours after application.

In this study 3,5,5-Trimethyl-ethyl capronate is not an eye irritant.