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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
To assess the dermal irritation potential of test chemical liquid in Vienna White rabbits
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material : N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-N-methylmethanaminium acetate- Molecular formula: C33H32N3C2H3O2- Molecular weight : 529.68 g/mol- Smiles notation : [N+](=C1/C=CC(\C=C1)=C(\c1ccc(c2ccccc12)Nc1ccccc1)c1ccc(cc1)N(C)C)(\C)C.C(C)(=O)[O-]- InChl : 1S/C33H31N3.C2H4O2/c1-35(2)27-18-14-24(15-19-27)33(25-16-20-28(21-17-25)36(3)4)31-22-23-32(30-13-9-8-12-29(30)31)34-26-10-6-5-7-11-26;1-2(3)4/h5-23H,1-4H3;1H3,(H,3,4)- Substance type:Organic- Physical state:Liquid
Specific details on test material used for the study:
- Name of test material: N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-N-methylmethanaminium acetate- Molecular formula: C33H32N3C2H3O2- Molecular weight: 529.68 g/mol- Smiles notation : [N+](=C1/C=CC(\C=C1)=C(\c1ccc(c2ccccc12)Nc1ccccc1)c1ccc(cc1)N(C)C)(\C)C.C(C)(=O)[O-]- InChl : 1S/C33H31N3.C2H4O2/c1-35(2)27-18-14-24(15-19-27)33(25-16-20-28(21-17-25)36(3)4)31-22-23-32(30-13-9-8-12-29(30)31)34-26-10-6-5-7-11-26;1-2(3)4/h5-23H,1-4H3;1H3,(H,3,4)- Substance type: Organic- Physical state: Liquid- Common Name: Victoria Blue B liquid- Analytical purity: 44% Victoria Blue B 45 % acetic acid 11 % propyleneglycol

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
no data available

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
2.5 x 2.5 cm
Duration of treatment / exposure:
4 h
Observation period:
1, 2 and 8 days
Number of animals:
2
Details on study design:
TEST SITE - Area of exposure: to the dorsal skin- % coverage: 2.5 x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: not specified
Time point:
other: not specified
Reversibility:
not specified
Remarks on result:
other: Exact evaluation not possible due to staining of the skin by the substance
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
2.6
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Exact evaluation for erythema was not possible due to staining of the skin by the substance.The skin findings on the sacrificed animal was confirmed by gross pathological examination after incision of the skin.

Any other information on results incl. tables

Observation Table:

Animal No.

4 hours

1 day

2 days

8 days

Reddening

Edema

Reddening

Edema

Reddening

Edema

Reddening

Edema

1

*

2e

*

3e

*

3e

*sSe

2e

2

*

2

*

3e

*

2e

*Se

1

S: scaling

s.S.: severe scaling

e: extending beyond the area of exposure

*Exact evaluation not possible due to staining of the skin by the substance.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Exact evaluation for erythema was not possible due to staining of the skin by the substance. The skin findings on the sacrificed animal were confirmed by gross pathological examination after incision of the skin. The edema formation exceeded beyond the area of exposure with mean score after 48 hours was 2.6 and was not reversible even after 8 days. Based on the observations and scores, the test chemical was strongly irritating to the skin.
Executive summary:

The dermal irritation potential of test chemical was assessed in rabbits. The study was performed as per OECD 404 Guidelines.

Undiluted test chemical was placed on a surgical gauze patch (2.5 cm x 2.5 cm) and applied to shaved dorsal skin of 2 Vienna White rabbits. The patch was covered with an occlusive dressing. The animals were exposed to the chemical for 4 hours. The animals were observed for signs of irritation at 1, 2 and 8 days post exposure. Exact evaluation for erythema was not possible due to staining of the skin by the substance. The skin findings on the sacrificed animal were confirmed by gross pathological examination after incision of the skin. The edema formation exceeded beyond the area of exposure with mean score after 48 hours was 2.6 and was not reversible even after 8 days. Based on the observations and scores, the test chemical was strongly irritating to the skin.