Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 Mar 1988 - 11 Mar 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 1987)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 2002)

Deviations:

yes

Remarks:

Use of 4 animals and no data on purity of test substance.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized

Molecular formula:

Unspecified

IUPAC Name:

Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized

Test material form:

liquid

Specific details on test material used for the study:

- Chemical name: Epoxystearinsaeure-2-ethylhexylester
- Physical state: colorless liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrusse Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Sex: male
- Age at study initiation: adult
- Weight at study initiation: 2.42 kg (mean)
- Housing: single housing
- Diet: Altromin diet 2023, Altromin GmbH, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM:
Draize scheme

READINGS:
1, 6, 24, 48, and 72 hours after application

TOOL USED TO ASSESS SCORE:
fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.08

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Conjunctivae findings were observed at 1, 6, and 24 h after treatment. 3/4 animals had a score of 1, 1/4 animals had a score of 2 after 1 hour. After 6 h 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance showed no eye irritating potential

Executive summary:

In a study according to OECD TG 405 (adopted 1987, GLP), the eye irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. 0.1 mL of the undiluted test substance was instilled into the rabbits eye and no washing was performed. Readings were performed 1, 6, 24, 48, and 72 hours after application. Conjunctivae findings were observed at 1, 6, and 24 h after treatment, where 3/4 animals had a score of 1 and 1/4 animals had a score of 2 after 1 hour. After 6 h, 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.