Tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Justification for type of information:

The study will be performed according to:
The Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice
Guidelines (1997).
Which essentially conform to:
The United States Food and Drug Administration Good Laboratory Practice Regulations.
The United States Environmental Protection Agency Good Laboratory Practice Regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione

EC Number:

227-285-6

EC Name:

Tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione

Cas Number:

5763-44-0

Molecular formula:

C7H9NO2

IUPAC Name:

4,5,6,6a-tetrahydro-3aH-cyclopenta[c]pyrrole-1,3-dione

Test material form:

solid: flakes

Test animals

Species:

human

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The solid test substance (10.7 to 10.9 mg ; with a samll galss weight boat) with 5 µl Milli-Q water was added into 12-well plates on the top of the skin tissues.

Duration of treatment / exposure:

15 minutes

Observation period:

incubation for 42 hours at 37°C.

Number of animals:

3 tissues per test substance

Details on study design:

negative control : 3 tissues treated with 10 µl PBS (phosphate buffered saline)
positive control : 3 tissues treated with 10 µl 5% SDS (sodium dodecyl sulphate)

After exposure, the tissues were washed with PBS to remove residual test substance. The cell culture inserts were dried carefully and moved to a new well on 2ml pre-warmed maintenance medium until all tissued were dosed and rinsed. After, tissues were incubated for 42 hours at 37°C.
After incubation, they were dried carefully and transferred into a 12-wells plate prefilled with 2ml MTT medium (03 mg/ml) and incubated 3h at 37°C. Afterward, tissues were placed on blotting papers, to be dried, and the biopsy occured.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

15 min

Value:

ca. 96

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The relative mean tissue viability obtained after 15 minutes treatment with tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione compared to the negative control tissues was 96%. Since the mean tissue viability for 852 imide brute was above 50%, the test item tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione was considered to be NON IRRITANT.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test is valid and the test item is considered as NON IRRITANT in the in vitro skin irritation test.