3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6th November - 14th November 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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:

3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

EC Number:

701-350-3

Molecular formula:

Not possible to assign, UVCB

IUPAC Name:

3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

Test material form:

liquid

Details on test material:

- Appearance: brown liquid
- Storage: room temperature, in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Male New Zealand White Rabbits ten to twelve weeks old, weighing between 2.57 and 2.70 kilograms at the start of the study were individually housed in stainless stell cages in a temperature, humidity and light controlled room. Purina Rabbit chow and water were available ad libitum. The animals were conditioned for at least 5 days prior to study initiation.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 mL of neat test material

Duration of treatment / exposure:

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 neat 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, residual material was removed from the site; and 30 minutes after
removal, the site was observed and scored

Observation period:

7 days

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

2

Reversibility:

fully reversible within: 4 days

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with GHS and OECD 404 guidelines, the substance is not classified for skin irritation

Executive summary:

The test susbtance was applied at a dose of

0.5 ml 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 0.5, 24, 48, 72 and 168 hours after test

substance removal. There were minor skin irritation reactions in all of the test subjects. The

maximum skin irritation score was 1.33 at the 24 hour observation.

In accordance with GHS and OECD 404 guidelines, the substance

is not classified for skin irritation.