Decanedioic acid, compound with ethanolamine / Decanedioic acid, compound with 2-aminoethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5th October 2017- 8th 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:

Sebacic acid, compound with 2-aminoethanol (1:2)

Molecular formula:

C10H18O4.2(C2H7NO)

IUPAC Name:

Sebacic acid, compound with 2-aminoethanol (1:2)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The Study was conducted using rabbits obtained from Kuiper Rabbitry, Gary, Indiana. The rabbits weighed from 2.74 to 2.83
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:

0.1ml

Duration of treatment / exposure:

The test article was ground into a fine powder prior to dosing and 0.1 ml packed volume was instilled into one eye 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

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

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. The test article was ground into a fine powder prior to dosing and the powdered
test article was used for dosing. Five minutes prior to dosing, the eyes were anesthetized with
Tetracaine HCL solution. Three animals were dosed by instilling 0.1 ml. packed volume 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:

ca. 0

Max. score:

0

Reversibility:

other: no observed effect

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no observed effect

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no observed effect

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no observed effect

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was instilled into the eyes of rabbits and the eyes were observed and scored at 1, 24, 48 and 72 hours. There were minimal eye irritation reactions in all of the test subjects which cleared by the 1 hour observation. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for eye irritation.

Executive summary:

The test substance potential to induce eye irritation was conducted in the OECD guidelines 405. 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.The test substance was instilled into the eyes of rabbits and the eyes were observed and scored at 1, 24, 48 and 72 hours. The eyes were examined at 1, 24, 48 and 72 hours after treatment. There were minimal eye irritation reactions in all of the test subjects which cleared by the 1 hour observation. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for eye irritation.

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