Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5th October 2017- 19th October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

EC Number:

268-793-8

EC Name:

Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

Cas Number:

68140-41-0

Molecular formula:

C18H34O2.C4H11NO

IUPAC Name:

oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

Test animals / tissue source

Species:

guinea pig

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The study was conducted using Female New Zealand White Rabbits ten to twelve weeks old. The rabbits were obtained from Kuiper Rabbitry, Gary, Indiana. The rabbits weighed from 2.20 to 2.59 kilograms at the start of the study and were individually housed in stainless steel cages in a temperature (63-73°F), humidity (30-70%), and light controlled room. Each rabbit was assigned a test animal number which appeared on a cage card visible on the front of each cage. The females were nulliparous and non-pregnant. The rabbits were maintained according to the recommendations contained in the National Academy Press 2011: "Guide for the Care and Use of Laboratory Animals". They were conditioned for at least five days prior to study initiation. Purina Rabbit chow and water were available ad libitum. All animals used for this study were considered to be in good health at the study initiation.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

0.1 ml of the test substance was instilled into the one eye and then holding the eye lids together for one second to prevent loss of the material

Observation period (in vivo):

24 hours

Details on study design:

24 hours before the start of the study both eyes of the experimental animals were examined for pre-existing ocular lesions. Only those animals with no pre-existing ocular lesions were used for test purposes. Five minutes prior to dosing, the eyes were anesthetized with Tetracaine HCL solution. Three animals were dosed by instilling 0.1 ml of the test article into one eye and then holding the eye lids together for one second to prevent loss of the material. The contralateral eye
served as the untreated control for each rabbit.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within:

Remarks:

14days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within:

Remarks:

7days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

14days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.78

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

14 days

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Following exposure of test substance to the eye of rabbits, there was severe irritation observed in all of the test subjects. The calculated mean score following grading at 24, 48 and 72 hours after installation of the test material, 3 animals showed positive responses of cornea opacity≥1, Iris ≥1, and conjunctival redness ≥2, while 2 animals showed positive response of conjunctival chemosis ≥2. All responses observed clear within 14days observation. Therefore, in accordance with the CLP guidance, the test substance meet the classification criteria for eye irritation and would be classified as H319; Causes serious eye irritation.

Executive summary:

The test substance was tested for eye irritation in accordance with OECD Guidelines (405). The test substance, a viscous paste was administered into one eye of each of three albino rabbits. The eyes were observed and scored at 1, 24, 48, 72,168 and 336 hours. There was severe irritation observed in all of the test subjects. Following exposure of test substance to the eye of rabbits, there was severe irritation observed in all of the test subjects. The calculated mean score following grading at 24, 48 and 72 hours after installation of the test material, 3 animals showed positive responses of cornea opacity≥1, Iris ≥1, and conjunctival redness ≥2, while 2 animals showed positive response of conjunctival chemosis ≥2.  All responses observed clear within 14days observation. Therefore, in accordance with the CLP guidance, the test substance meet the classification criteria for eye irritation and would be classified as H319; Causes serious eye irritation.