Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

An animal model assessment of common dye-induced allergic contact dermatitis

Author:

JOE DINARDO, Raleigh N, C; and ZOE DIANA DRAELOS

Year:

2007

Bibliographic source:

j. Cosmet. Sci.., 58, 209-214 May - june

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Given below

Principles of method if other than guideline:

To evaluate the skin sensitization potential of Basic Violet 1 in guinea pig by modified Buehler and Klecak method.

GLP compliance:

not specified

Type of study:

other: Modified Buehler and Klecak method

Test material

Test material information

Constituent 1

Reference substance name:

C.I. Basic Violet 1

IUPAC Name:

C.I. Basic Violet 1

Constituent 2

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:

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

Induction 1

Route:

epicutaneous, open

Vehicle:

propylene glycol

Induction 2

Concentration / amount:

induction concentration of 10%
challenge concentrations of 10.0%, 5.0%, and 2.5%

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

propylene glycol

Challenge 2

Concentration / amount:

induction concentration of 10%
challenge concentrations of 10.0%, 5.0%, and 2.5%

No. of animals per dose:

10

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period: 24 and 48 hour
- Test groups: 10
- Control group: no data
- Site: the left flanks of ten albino guinea pigs were shaved
- Frequency of applications: three times weekly (Monday, Wednesday Friday) for three consecutive weeks.
- Duration: 3 weeks
- Concentrations:10%

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: Two week rest period
- Exposure period:
- Test groups: 10
- Control group:
- Site: right flank of each guinea pig was shaved
- Concentrations: 100%,50%, and 25%
- Evaluation (hr after challenge): 24 hour

Positive control substance(s):

yes

Remarks:

DNCB (2,4-dinitrochlorobenze)

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)

Results

Reading:

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.

Hours after challenge:

24

Group:

test chemical

Dose level:

induction concentration of 10% challenge concentrations of 10.0%, 5.0%, and 2.5%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No sensitization.

Remarks on result:

other: see Remark

Remarks:

Reading: 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.. . Hours after challenge: 24.0. Group: test group. Dose level: induction concentration of 10% challenge concentrations of 10.0%, 5.0%, and 2.5% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No sensitization..

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance Basic violet 1 was observed to be non -sensitizing in guinea pig by modified Buehler and Klecak method.

Executive summary:

Skin sensitization test for Basic violet 1 was conducted in guinea pig usingmodified 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. 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 concentration(100%,50%, and 25% of the induction concentration) 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 substance was considered as not sensitizing to the skin.