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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Basic Blue 991
Author:
Cosmetic Ingredient Review expert
Year:
2007
Bibliographic source:
International Journal of Toxicology, 26(Suppl. 2):51–63, 2007

Materials and methods

Objective of study:
absorption
Principles of method if other than guideline:
In Vivo Absorption study of Basic Blue 99 in Sprague-Dawley rats
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report):Basic Blue 99- Molecular formula (if other than submission substance):C19H20BrN4O2•Cl- Molecular weight (if other than submission substance):451.75 g/mole- Substance type:Organic- Physical state:Solid- Impurities (identity and concentrations):37 %
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified

Administration / exposure

Route of administration:
dermal
Vehicle:
not specified
Details on exposure:
Rats were treated topically with 200 μl of an aqueous Basic Blue 99 (14C labeled) hair setting solution to assess its skin permeation potential. Approximately 31.3 μg Basic Blue 99/cm2 skin was applied at a volume of 0.2 ml over a 1.5 × 1.5-cm area on intact, clipped dorsal aspect of the thorax.
Duration and frequency of treatment / exposure:
24 h
Doses / concentrations
Remarks:
Doses / Concentrations:31.3 μg
No. of animals per sex per dose:
Three
Control animals:
not specified
Positive control:
Data not available
Details on study design:
One hour later each rat was fitted with a collar to prevent licking the area of application. Urine and feces were analyzed 24 h after application.
Details on dosing and sampling:
Data not available
Statistics:
Data not available

Results and discussion

Preliminary studies:
Data not available
Main ADME results
Type:
absorption
Results:
very low percutaneous absorption.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Levels of 14C were low in the urine (< 0.02%) and feces (<0.07%) of two rats. The third rat excreted more than 5.05 % of 14C dose in urine, but only 0.12% in feces. Basic Blue 99 have very low percutaneous absorption.
Details on distribution in tissues:
Data not available
Details on excretion:
Data not available

Metabolite characterisation studies

Metabolites identified:
not specified
Details on metabolites:
Data not available

Bioaccessibility

Bioaccessibility testing results:
Data not available

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study resultsOn the basis of observed result it is concluded the Basic Blue 99 have very low percutaneous absorption and expected to have Low bio-accumulation potential based on study results.
Executive summary:

In a in vivo Absorption study, three Sprague-Dawley rats were treated topically with 200 μl of an aqueous Basic Blue 99 (14C labeled) hair setting solution. Approximately 31.3 μg Basic Blue 99/cm2skin was applied at a volume of 0.2 ml over a 1.5 × 1.5-cm area on intact, clipped dorsal aspect of the thorax. Levels of14C were low in the urine (< 0.02%) and feces (<0.07%) of two rats. The third rat excreted more than 5.05 % of14C dose in urine, but only 0.12% in feces.Therefore, on the basis of observed result it is concluded the Basic Blue 99 have very low percutaneous absorption and expected to have Low bio-accumulation potential based on study results.