Registration Dossier

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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.