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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
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 is from publication .

Data source

Reference
Reference Type:
publication
Title:
An animal model assessment of allergic contact dermatitis of test chemicals
Author:
DINARDO et.al
Year:
2007
Bibliographic source:
JOURNAL OF COSMETIC SCIENCE,2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: modified Buehler and Klecak method
Principles of method if other than guideline:
Modified Buehler and Klecak method was performed to evaluate the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
Currently no LLNA study was available for assessment

Test material

Constituent 1
Chemical structure
Reference substance name:
8004-87-3
EC Number:
616-846-4
Cas Number:
8004-87-3
Molecular formula:
C24H28ClN3
IUPAC Name:
8004-87-3
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): C.I. Basic Violet 1
- Molecular formula: C24H28ClN3
- Molecular: 393.95 g/mol
- Substance type: Organic

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino guinea pigs
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
10%
Day(s)/duration:
24 and 48 hours exposure for 3 weeks
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
10.0%, 5.0%, and 2.5%
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10 animals
Details on study design:
Details on study design
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period:48 hour
- Test groups: 10
- Control group: no data
- Site: the left flanks of ten albino guinea pigs were shavedand the test material applied three times weekly( Monday,Wednesday,Friday)for three consecutiv weeeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area.
- Frequency of applications: three times weekly (Monday, Wednesday Friday) for three consecutive weeks.
- Duration: 3 weeks
- Concentrations:10%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Two week rest period
- Exposure period: 24 hour
- Test groups: 10
- Control group: No data available.
- Site: right flank of each guinea pig was shaved and test material applied on it.
- Concentrations: 10.0%, 5.0%, and 2.5%
- Evaluation (hr after challenge): 24 hour and 48 hours post-application

Other – The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase.
Challenge controls:
No data available.
Positive control substance(s):
yes
Remarks:
DNCB (2,4-dinitrochlorobenze)

Results and discussion

Positive control results:
The positive control DNCB (2,4-dinitrochlorobenze) control at the 0.5% induction /challenge concentration elicited positive response in all animals tested.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10.0%, 5.0%, and 2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No sensitization reaction observed.
Remarks on result:
no indication of skin sensitisation
Reading:
other: challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10.0%, 5.0%, and 2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin sensitization reaction observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Table 1: Allergic contact dermatitis of dyes

Induction concentration in propylene glycol

Challenge concentration in propylene glycol*

10%

5%

2.5%

10%

Negative

Negative

negative

 

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
No erythema/edema was observed after application of test material.The test result was observed to be negative for the test substance. Therefore, the test chemical was considered to be not sensitizing to the skin of guinea pigs.
Executive summary:

A modified Buehler and Klecak method for open epicutaneous testing[OET] was performed to assess the sensitization potential of the test chemical.The test chemical was tested at an induction concentration of 10% and challenge concentrations of 10.0%, 5.0%, and 2 .5% in propylene glycol.During the induction phase, the left flanks of ten albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday, Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentrations in propylene glycol(10.0%, 5.0%, and 2 .5%). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale.A positive control of 0.5% 2,4-dinitrochlorobenzene(DNCB) in ethanol was included for both the induction and challenge phases. No erythema/edema was observed after application of test material.The test result was observed to be negative for the test substance. Therefore, the test chemical was considered to be not sensitizing to the skin of guinea pigs.