3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride

Basic toxicokinetics

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

Test material information

Constituent 1

Reference substance name:

3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride

EC Number:

268-544-3

EC Name:

3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride

Cas Number:

68123-13-7

Molecular formula:

C19H20BrN4O2.Cl

IUPAC Name:

3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride

Constituent 2

Reference substance name:

Basic Blue 99

IUPAC Name:

Basic Blue 99

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 / concentration:

Three

Control animals:

not specified

Positive control reference chemical:

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 (or Bioavailability)

Bioaccessibility (or Bioavailability) 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.