Benzamide, N,N-dibutyl-4-[4-(4-chlorophenyl)-2,3,5,6-tetrahydro-3,6-dioxopyrrolo[3,4-c]pyrrol-1-yl]-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November to December 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline under GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

K-36

IUPAC Name:

K-36

Constituent 2

Reference substance name:

N,N-dibutyl-4-[4-(4-chlorophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzamide

Cas Number:

1391764-61-6

Molecular formula:

C27H28ClN3O3

IUPAC Name:

N,N-dibutyl-4-[4-(4-chlorophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

human

Details on test animals or test system and environmental conditions:

human skin model; 37°C ± 2°C, 5% CO₂ ± 2%, 70 - 100% humidity

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

The test item was applied topically to the each skin equivalent by using a plastic spoon. Because of the low density of the test item at least 20mg were applied.

Duration of treatment / exposure:

The test item “K-36” was tested according to OECD-Guideline 431 in the In Vitro test via human skin model over a time period of 3 minutes and 60 minutes. The 3 min incubation was performed at RT and the 60 min exposure was incubated at 37°C ± 2°C, 5% CO₂ ± 2%, 70 - 100% humidity.

Observation period:

60 min

Number of animals:

0 - in-vitro test

Details on study design:

epiCS Epidermal Skin Test

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Viability (%)

Basis:

mean

Time point:

other: 3

Score:

87.3

Results 2

Irritation parameter:

other: Viability (%)

Basis:

mean

Time point:

other: 60

Score:

85

Irritant / corrosive response data:

No irritant/ corrosive response

Applicant's summary and conclusion

Interpretation of results:

other: non-corrosive

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

The test item “K-36” was considered to be non-corrosive to skin according to OECD Guideline 431. The positive controls prove additionally the well functioning of the skin models.

Executive summary:

The test item “K-36” was tested according to OECD-Guideline 431 in the In Vitro test via human skin model over a time period of 3 minutes and 60 minutes. According to the definition of the OECD-Guideline 431 the test item was considered to be non-corrosive.