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

Endpoint summary

Description of key information

Basic Blue 99 have very low  oral absorption and excretion, and expected to have Low bio-accumulation potential based on study results.

Key value for chemical safety assessment

Bioaccumulation potential:

low bioaccumulation potential

Absorption rate - oral (%):

2.8

Absorption rate - dermal (%):

10.1

Additional information

In a report given by Cosmetic Ingredient Review expert (2007), in vivo absorption of Basic Blue 99 (¹⁴C labeled) evaluated in three Sprague-Dawley rats treated topically with 200 μl of an aqueous Basic Blue 99 (¹⁴C labeled) hair setting solution. 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.

In a similar report, two female volunteers treated topically with¹⁴C-labeled Basic Blue 99 added in a setting lotion (40% aqueous solution containing 0.1% of other Arianor dyes) and applied with rollers to the hair of the volunteers. Levels of¹⁴C in the urine were low in both volunteers (0.037% and 0.027%). The penetration would be less than 0.1% of the applied dose.

In a similar report, Wistar 2 male and 2 female rats were treated topically with 100 μl of an aqueous 1% Basic Blue 99 (14C labeled) solution. Total amount of¹⁴C Basic Blue 99 that penetrated the skin was 0.14% in male and 0.06% female. The highest absorption was observed in the anionic shampoo, then in the cationic and nonionic bases, and with the lowest penetration observed with the aqueous solution. However, even the highest absorption was very low and it is considered as insignificant.

In similar 4^threport, Wistar 4 female rats were treated topically with 100 μl of an aqueous 1% Basic Blue 99 (¹⁴C labeled) solution in a 50% aqueous anionic shampoo base. Small amounts of¹⁴C were detected in the urine (1.16%), feces (0.53%), and carcass (0.03%). Only 1.72% of the applied dye penetrated the skin under occlusive conditions. Penetration was reduced in animals that were rinsed after application;¹⁴C was detected in the urine and feces (0.02%), blood and carcass (<0.001%), and only 2.9% of the applied material remained on the skin surface at 48 h after treatment. However, even the highest absorption was very low and it is considered as insignificant.

In similar 5^threport, Wistar4 female rats were treated topically with 100 mg of 0.5% Basic Blue 99 (14C labeled) in nonionic/cationic shampoo base. Small amounts of¹⁴C were detected in the urine, feces, and carcass (0.5%) with <0.001% in blood. Penetration was reduced in animals that were rinsed after application;¹⁴C was detected in the urine (0.01%), feces (0.02%), blood and carcass (<0.001%), and 1.68% of the applied material remained on the skin surface at 48 h after treatment. Most of the radioactivity was recovered in the rinsing (99%) and 1.3% was on the patch.

In similar 6^threport, Wistar 3 male and 3 female rats were treated with a single oral dosage of¹⁴C-labeled Basic Blue 99 (1.0 ml of an aqueous 0.1% solution). It was observed that most of the¹⁴C was recovered in the feces within the first 24 h. The urine contained 0.68% and 0.5% of the dose from male and female rats, respectively. Levels of¹⁴C were barely detectable in expired air and were very low in the blood and carcass (<0.001%). Basic Blue 99 is poorly absorbed from the intestinal tract.

In similar above report, in vivo absorption and Excretion of Basic Blue 99 were evaluated in Sprague-Dawley 2 male rats treated with a single oral dosage of (1 ml) ¹⁴C-labeled Basic Blue 99 and another two rats were administered Basic Blue 99 orally. Most of the¹⁴C was recovered in the feces in both study groups within the first 24 h. The urine contained 10.1% or 3.3% of the dose after intraperitoneal administration and 2.8% or 3.1% after oral administration. Basic Blue 99 was poorly absorbed.

Therefore, on the basis of above all observed result it is concluded that the Basic Blue 99 (CAS no 68123-13-7) has very low percutaneous or oral absorption and excretion, and expected to have Low bio-accumulation potential based on study results.