Fatty acids, C10-20-neo-

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:

other: Well documented study following standard guidelines and performed following GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C10-20-neo-

EC Number:

285-549-6

EC Name:

Fatty acids, C10-20-neo-

Cas Number:

85116-96-7

Molecular formula:

C10H20O2 ... C20H40O2

IUPAC Name:

C10-20-neo-Fatty acids

Details on test material:

- Name of test material (as cited in study report): Versatic 1019
- Substance type: brown liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Limited
- Age at study initiation: young adult
- Weight at study initiation: 2440-2790 g
- Housing: individually in aluminum cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1
- Humidity (%): 45
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): n/a

Duration of treatment / exposure:

Material was instilled into the eye and held shut for one second

Observation period (in vivo):

1 h, 24 h, 48 h, 72 h after treatment

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 4 out of 10

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

0.67

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 0.67 out of 10

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

0.33

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 0.33 out of 10

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hour average

Score:

0

Max. score:

0

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hour averages

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

Under the conditions of the study, Versatic 1019 was considered slightly, but transiently, irritating to the rabbit eye.

Executive summary:

Versatic 10 (neodecanoic acid) was tested for eye irritancy in one eye of each of three rabbits. Eye responses were scored at 1, 24, 48, and 72 hours after treatment according to the method of Draize. At 1 hour after treatment, animals showed slight redness of the conjunctivae, and severe discharge. In all animals, recovery was advanced by 48 hours after treatment and the remaining eye responses had resolved completely by 72 hours after treatment.