4-(2-{(E)-2-[(1E)-1-{(2E)-2-[1,1-dimethyl-3-(4-sulfobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-{methyl[(trifluoromethyl)sulfonyl]amino}-1H-inden-3-yl]vinyl}-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate compound with N,N-diethylethanamine (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Principles of method if other than guideline:

/

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-(2-{(E)-2-[(1E)-1-{(2E)-2-[1,1-dimethyl-3-(4-sulfobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-{methyl[(trifluoromethyl)sulfonyl]amino}-1H-inden-3-yl]vinyl}-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate compound with N,N-diethylethanamine (1:1)

EC Number:

940-889-0

Cas Number:

1770781-13-9

Molecular formula:

C51 H52 F3 N3 O8 S3 . C6 H15 N

IUPAC Name:

4-(2-{(E)-2-[(1E)-1-{(2E)-2-[1,1-dimethyl-3-(4-sulfobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-{methyl[(trifluoromethyl)sulfonyl]amino}-1H-inden-3-yl]vinyl}-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate compound with N,N-diethylethanamine (1:1)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

97.85% pure, 0.87% water, green-brown powder

Test animals

Details on test animals or test system and environmental conditions:

in vitro test. EPISKIN small model is used.

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

other:

Amount / concentration applied:

3 tissues were tested per test substance together with negative and positive controls.

Duration of treatment / exposure:

42 hours at 37°C

Observation period:

after incubation, cell culture inserts were dried carefully to remove excess medium and were transferred. the tissues were incubated for 3h at 37°C.

Number of animals:

/

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: remaining cell viability after exposure

Value:

76

Remarks on result:

other:

Remarks:

Basis: other: relative mean tissue viability compared to negative control tissue. Remarks: percentage. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: remaining cell viability after exposure

Value:

22

Remarks on result:

other:

Remarks:

Basis: other: mean relative tissue viability compared to negative control. Remarks: percentage. (migrated information)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Finally, it is concluded that this test is valid and that CH03938 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.