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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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:
Dermal irritation capability of basic blue 99 was tested on albino rabbits .
GLP compliance:
not specified

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:SolidPurityAccording 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.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
other: Patch
Preparation of test site:
other: Shorn intact or abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 g per square inch
Duration of treatment / exposure:
24 Hr
Observation period:
14 day
Number of animals:
3/sex/dose
Details on study design:
TEST SITE- Area of exposure: short intact or abraded skin on the back of animal- % coverage: No data available- Type of wrap if used: patchREMOVAL OF TEST SUBSTANCE- Washing (if done): No data available.- Time after start of exposure: No data available.SCORING SYSTEM: No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 Hrs
Reversibility:
no data
Remarks on result:
other: No observable skin irritation.
Irritant / corrosive response data:
No data available
Other effects:
No data available

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Basic Blue 99 is non irritating to the skin of New Zealand White rabbits.
Executive summary:

Dermal irritation study was carried out to test the dermal toxicity of basic blue 99 at the concentration of 0.5g per inch square.Basic Blue 99 (0.5 g per square inch) was applied undiluted to either the shorn intact or abraded skin on the back of animals. The patch was affixed for 24 h. No observable reactions to Basic Blue 99 were noted over the 14-day observation period.According to the CLP classification, the test material Basic Blue 99 does not classify as a skin irritant.