2-ethylhexanoic acid, monoester with propane-1,2-diol

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Existing in vivo study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 June to 30 June 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study carried out in accordance with OECD 405 (1987) and performed with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxypropyl 2-ethylhexanoate

EC Number:

261-499-0

EC Name:

2-hydroxypropyl 2-ethylhexanoate

Cas Number:

58921-10-1

Molecular formula:

C11H22O3

IUPAC Name:

2-hydroxypropyl 2-ethylhexanoate

Constituent 2

Reference substance name:

1-hydroxypropan-2-yl 2-ethylhexanoate

Molecular formula:

C11H22O3

IUPAC Name:

1-hydroxypropan-2-yl 2-ethylhexanoate

impurity 1

Reference substance name:

Monoesters of 2-ethylhexanoic acid and dipropyleneglycol

IUPAC Name:

Monoesters of 2-ethylhexanoic acid and dipropyleneglycol

impurity 2

Reference substance name:

1-methylethylene 2-ethylhexanoate

EC Number:

301-185-3

EC Name:

1-methylethylene 2-ethylhexanoate

Cas Number:

93981-97-6

Molecular formula:

C19H36O4

IUPAC Name:

propane-1,2-diyl bis(2-ethylhexanoate)

impurity 3

Reference substance name:

2-ethylhexanoic acid

EC Number:

205-743-6

EC Name:

2-ethylhexanoic acid

Cas Number:

149-57-5

Molecular formula:

C8H16O2

IUPAC Name:

2-ethylhexanoic acid

impurity 4

Reference substance name:

Propane-1,2-diol, propoxylated

EC Number:

500-039-8

EC Name:

Propane-1,2-diol, propoxylated

Cas Number:

25322-69-4

IUPAC Name:

Propane-1,2-diol, propoxylated

impurity 5

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Test material form:

liquid: viscous

Specific details on test material used for the study:

- Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (very pale yellow)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.88 to 3.10 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
VEHICLE no vehicle used

Duration of treatment / exposure:

1 h

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3 (1 female, 2 males)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed, but it is not considered necessary
The eyes of the animals were examined 1, 24, 48, and 72 h after the test substance application. The light source from a standard ophthalmoscope was used.

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope was used to enable the assessment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.2

Max. score:

1

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Irritant / corrosive response data:

No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h.

Any other information on results incl. tables

Individual irritation scores can be found in the attached document below.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not an eye irritant.

Executive summary:

In this eye irritation study, 0.5 ml of SER-AD FX 511 was instilled into the conjunctival sac of the right eye of 3 young adult New Zealand White rabbits (1 female and 2 males). Animals were then observed for the following 72 h. Irritation was scored using the Draize scheme for unwashed eyes at time point of 24, 48 and 72 h post-treatment. No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h. SER-AD FX 511 induced slight irritation that was reversed during the study period. On the basis of this study, SER-AD FX 511 does not warrant classification as being an eye irritant.