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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from peer-reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final Report on the Safety Assessment of Basic Violet dyes
Author:
Catherine Diamante et.al
Year:
2009
Bibliographic source:
International Journal of Toxicology, 2009
Reference Type:
publication
Title:
Contact-Group Sensitization to Triphenylmethane Dyes
Author:
Novák M et.al
Year:
1969
Bibliographic source:
Arch Dermatol, 1969

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Patch tests were performed to evaluate the degree of allergic reactions caused by the test chemical
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride- Common Name: Basic Violet 3- Molecular formula :C25H30N3.Cl- Molecular weight :407.986g/mol- Substance type:Organic - Physical state:Solid

In vivo test system

Test animals

Species:
other: Humans
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
2% in water
Day(s)/duration:
20-24 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
2% in water
Day(s)/duration:
20-14 hours
Adequacy of challenge:
not specified
No. of animals per dose:
11 volunteers
Details on study design:
Other: The patch tests were put on for 20 to 24 hours and they were evaluated for six to seven days. Since the skin is colored by the tested dye, it was not possible to evaluate the erythematous reaction. For this reason evaluation was recorded as follows:Itching = ±Isolated papules = +Edema, confluent papules, infiltration= + +Vesicular reaction = + + +
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Positive control substance(s):
not specified
Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2% in water
No. with + reactions:
8
Total no. in group:
11
Clinical observations:
itching +; isolated papules +; edema, confluent papules, and infiltration ++; or vesicular reaction+++ was observed
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Patch test responses

Volunteer number

Reactions to the Test chemical

1

+

2

+++

3

+

4

+

5

+

6

++

7

-

8

+

9

-

10

-

11

++

 

 

Applicant's summary and conclusion

Interpretation of results:
other: sensitizing
Conclusions:
Positive reactions to the test chemical were observed in 8 of the 11 volunteers tested.Edema, confluent papules, infiltration were observed in 2 of 11 volunteers; vesicular reaction was noted in 1 volunteer.The test material was considered to be a skin sensitizer.
Executive summary:

Patch tests were performed to evaluate the degree of allergic reactions caused by the test material

The patch tests were put on for 20 - 24 hours on the skin of 11 volunteers. They were evaluated for six to seven days. Since the skin got colored by the test chemical, it was not possible to evaluate the erythematous reaction. For this reason evaluation was recorded as follows:

Itching = ±

Isolated papules = +

Edema, confluent papules, infiltration= + +

Vesicular reaction = + + +

Positive reactions to the test chemical were observed in 8 of the 11 volunteers tested.

Edema, confluent papules, infiltration were observed in 2 of 11 volunteers; vesicular reaction was noted in 1 volunteer.

The test material was considered to be a skin sensitizer.