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

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- 1st 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:

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The study was conducted using approximately ten to twelve weeks old male rabbits obtained from Kuiper Rabbitry, Gary, Indiana. The rabbits weighed from 3.22 to 3.47 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:

water

Remarks:

Moistened with water to assure good contact

Controls:

yes

Amount / concentration applied:

0.5g of neat test substance

Duration of treatment / exposure:

4 hours exposure to test substance

Observation period:

168 h0urs

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 g aliquot of the test
material, which was slightly moistened w/water to assure good skin contact, 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 and168 hours after treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No erythema was observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No erythema was observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following exposure to test ubstance, the application sites were graded for indication of skin reactions at 4.5, 24, 48 and 72 hours. There were no skin irritation reactions in any of the test subjects. The maximum skin irritation score was 0. Therefore, In accordance with the criteria set forth in the CLP Guidiances, the test substance will not be classified for skin irritation.

Executive summary:

The Skin irritation potential of the test substance was conducted in accordance with the OECD 404 guildelines. The test substance an off white solid, was applied at a dose of 0.5 g to an unabraded site on a clipped area of each of three albino rabbits. The application sites were graded for indication of skin reactions at 4.5, 24, 48 and 72 hours after test substance application. There were no skin irritation reactions in any of the test subjects. The maximum skin irritation score was 0, and the primary skin irritation index was calculated to be 0. Therefore, In accordance with the criteria set forth in the CLP Guidiances, the test substance will not be classified for skin irritation.

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