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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:
Contact sensitization study
Author:
JOE DINARDO
Year:
2007
Bibliographic source:
j. Cosmet. Sci.., 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Given below
Principles of method if other than guideline:
To evaluate the skin sensitization potential of test chemical in guinea pig by modified Buehler and Klecak method for open epicutaneous test
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
Not specified.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Dye
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:
not specified
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:
3 weeks
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
10.0%, 5.0%, and 2.5%
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10 animals
Details on study design:
Details on study designMAIN STUDYA. 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 timesweekly( 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-applicationOther – 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)

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

Positive control results:
The positive 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 group
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 group
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

In vivo (LLNA)

Cellular proliferation data / Observations:
No indication of skin sensitization observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
The test chemical was observed for its skin sensitizing potential inguinea pig .The test substance was observed to be non -sensitizing in guinea pig by modified Buehler and Klecak method.
Executive summary:

Skin sensitization test for test chemical was conducted in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. For the induction phase, the left flanks of 10 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. After a rest period of two weeks, in challenge phase the right flank of each guinea pig was shaved and exposed to three different concentration10.0%, 5.0%, and 2.5%.Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. 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 pig using modified Buehler and Klecak method for open Epicutaneous testing.