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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29th August 2017 to 5th September 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Male New Zealand White Rabbits approximately ten to twelve weeks old were used for this study.
The rabbits were obtained from Kuiper Rabbitry, Gary, Indiana. The rabbits weighed from 2.88 to 3.20
kilograms at the start of the study and were individually housed in stainless steel cages in a
temperature (20 ± 3° C), humidity (30-70%), and (12 hour/cycle) light controlled room. Each rabbit was
assigned a test animal number which appeared as an ear tag and also appeared on a cage card visible
on the front of each cage. The rabbits 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 Laboratory Rabbit Chow and water were available ad libitum. All animals used
for this study were considered to be in good health at study initiation.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 animals

Details on study design:

The day before study initiation, electric clippers were used to remove the hair from the left side of the trunk, from the midline of the back to the abdomen. The following day a 0.5 ml aliquot of the test material was then applied to an area approximately 6 square centimeters on the side of the test animal. The application site is located approximately 5-7 centimeters down from the backbone. The test substance was then covered with a 2.5 cm² - 2 layer gauze patch held in place with non-irritating Kendall Curity Standard Porous Tape and the patch was then covered with a semi-occlusive plastic overwrap secured in place with Kendall Curity Standard Porous Tape for the duration of the exposure period. At the end of the 4 hour contact period, excess material was removed from the site; the site being observed and scored. Dermal irritation readings for erythema and edema were performed approximately 4.5, 24, 48, 72 and 168 hours after treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.89

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within:

Remarks:

7 days

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The application sites were graded for indication of skin reactions at 4.5, 24, 48, 72 and 168 hours after test substance application. There were minor skin irritation reactions in all of the test subjects. The maximum skin irritation score was 2 for erythema and 1 for oedema at the 72 hour observation. The mean value for erythema was 1.89 and oedema was 0.67 in the 3 animals from grading’s at 24, 48 and 72 hours after patch removal. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for Skin irritation.

Executive summary:

The study was conducted in accordance with the OECD guideline, 404, to determine its skin irritation potential by applying 0.5ml of the test on unabraded site, left side of the trunk from the midline of the back to the abdomen, of 3 albino rats. The excess material was removed from the site after 4 hours and the site was observed and scored. Dermal irritation readings for erythema and oedema were performed approximately 4.5, 24, 48, 72 and 168 hours after treatment. There were minor skin irritation reactions in all of the test subjects. The maximum skin irritation score was 2 for erythema and 1 for oedema at the 72 hour observation. The mean value for erythema was 1.89 and oedema was 0.67 in the 3 animals from grading’s at 24, 48 and 72 hours after patch removal. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for Skin irritation.

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