Registration Dossier
Registration Dossier
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EC number: 229-792-8 | CAS number: 6737-68-4
Skin sensitisation
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 is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- An animal model assessment of common dye-induced allergic contact dermatitis.
- Author:
- JOE DINARDO, Raleigh, NC and ZOE DIANA DRAELOS
- Year:
- 2 007
- Bibliographic source:
- Journal of Cosmetic Science, 58, no. 3 (2007): 209-214
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Skin sensitization study was performed for test chemical Disperse violet 4 (CAS No: 1220-94-6) in guinea pigs by using modified Buehler and Klecak method.
- GLP compliance:
- not specified
- Type of study:
- other: a modified Buehler and Klecak method
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 1-amino-4-(methylamino)-9,10-dihydroanthracene-9,10-dione
- Cas Number:
- 1220-94-6
- Molecular formula:
- C15H12N2O2
- IUPAC Name:
- 1-amino-4-(methylamino)-9,10-dihydroanthracene-9,10-dione
- Test material form:
- solid
- Details on test material:
- - Name of test material : Disperse violet 4
- Molecular formula: C15H12N2O2
- Molecular weight: 252.272 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: c12c(C(c3ccccc3C1=O)=O)c(ccc2NC)N
- InChI: 1S/C15H12N2O2/c1-17-11-7-6-10(16)12-13(11)15(19)9-5-3-2-4-8(9)14(12)18/h2-7,17H,16H2,1H3
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : Disperse violet 4
- Molecular formula: C15H12N2O2
- Molecular weight: 252.272 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: c12c(C(c3ccccc3C1=O)=O)c(ccc2NC)N
- InChI: 1S/C15H12N2O2/c1-17-11-7-6-10(16)12-13(11)15(19)9-5-3-2-4-8(9)14(12)18/h2-7,17H,16H2,1H3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino
- 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% (0.1mL)
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10.0%, 5.0%, and 2.50%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hour
- Test groups: 10
- Control group: no data
- Site: shaved left flanks of ten albino guinea pigs 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 hours
- Test groups: 10
- Control group:
- Site: shaved left flanks of ten albino guinea pigs
- Concentrations: 10.0%, 5.0%, and 2.50%
- Evaluation (hr after challenge): 24 hour and 48 hours - Positive control substance(s):
- yes
- Remarks:
- 0.5% DNCB
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:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10.0%, 5.0%, and 2.50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema/edema was observed after 24 and 48 hours post-application.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No erythema/edema was observed after 24 and 48 hours post-application
Any other information on results incl. tables
All 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 and
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
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test substance Disperse violet 4 (CAS No: 1220-94-6) was considered to be non -sensitizing in guinea pig by modified Buehler and Klecak method.
- Executive summary:
Skin sensitization test for Disperse violet 4 (CAS No:1220-94-6) 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 test materialDisperse violet 4wasapplied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the 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 (10.0%, 5.0%, and 2.50%of the induction concentration).
Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.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.
No erythema/edema was observed after 24 and 48 hours post-application. Hence the test substanceDisperse violet 4(CAS No:1220-94-6)was considered as not sensitizing to the guinea pigs skin.
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