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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Basic Blue 99
Author:
American College of Toxicology
Year:
2007
Bibliographic source:
International Journal of Toxicology, 26(Suppl. 2):51–63, 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Guinea pig maximisation test was performed to evaluate the sensitizing potential of Basic Blue 99.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not known

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Basic Blue 99- Molecular formula (if other than submission substance): C19-H20-Br-N4-O2.Cl- Molecular weight (if other than submission substance): 451.75 g/mol- Substance type: Organic- Physical state: Solid- Purity According to the Keystone Aniline Corporation (1999) the chemical is atleast 63% pure Another supplier of Basic Blue 99 (Henkel 1992) has a specification of 60.7% dye content- Impurities (identity and concentrations): According to the Keystone Aniline Corporation (1999) have no more than 100 ppm of ironAnother supplier of Basic Blue 99 (Henkel 1992) suggests the presence of 25.7% sugar content, 11.8% inorganic salts, and 1.8 % volatile matter/water crystallization.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Details on test animalTEST ANIMALS- Source:- Age at study initiation: No data available- Weight at study initiation: No data available- Fasting period before study: No data available- Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction phase: 0.1% w/v, 75%Chellenge exposure: 25%
Challengeopen allclose all
Route:
other: Epicutaneous, closed
Vehicle:
water
Concentration / amount:
Induction phase: 0.1% w/v, 75%Chellenge exposure: 25%
No. of animals per dose:
10 Females
Details on study design:
Details on study designRANGE FINDING TESTS: No data availableMAIN STUDYA.1. INDUCTION EXPOSURE- No. of exposures: 3- Exposure period: No data available- Test groups: 10- Control group: No data available- Site: 4×6-cm area of dorsal skin on the scapular region- Frequency of applications: 3- Duration: No data available- Concentrations: 0.1% w/vA.2. INDUCTION EXPOSURE- No. of exposures: 1- Exposure period: 48 hrs- Test groups: 10- Control group: No data available- Site: 3×6-cm patch- Frequency of applications: 1- Duration: 48 hrs- Concentrations: 75%B. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: Two weeks after second induction period- Exposure period: 24 hrs- Test groups: 10- Control group: No data available- Site: flank- Concentrations: 25%- Evaluation (hr after challenge): 24, 48, and 72 hrsOTHER: No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
25% challenge group
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No evidence of delayed type hypersensitivity observed.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25% challenge group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No evidence of delayed type hypersensitivity observed..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Basic Blue 99 is non sensitizing to the skin of Guinea pigs
Executive summary:

Guinea pig maximisation test was performed to evaluate the sensitizing potential of Basic Blue 99 on 10 female albino Hartley/Dunkin guinea pigs.

Basic Blue 99 is non sensitizing to the skin of Guinea pigs.

According to the CLP classification, the test material Basic Blue 99 does not classify as a skin sensitizer.