tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate

Endpoint summary

Description of key information

No adverse effects were observed after feeding rats for four weeks with a diet containing 12000 ppm (ca 1100 mg/kg bw) of the substance (OECD 407, GLP). 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

1 075 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

For the range-finding study, the substance was given in the diet for 2 weeks at dietary levels of 0, 120, 1200, and 12000 ppn (= mg/kg food) to a total of 40 albino rats, 5 males and 5 females per dose group (Ciba-Geigy 1993c). Corrected for the analytically determined concentrations in the diet , the mean daily intake was 12.2, 125 and 1110 mg/kg bodyweight in males, and 12.7, 127 and 1120 mg/kg bodyweight in females. Reddish discoloration of feces due t o the red test article was noted i n groups 3 and 4 (1200 and 12000 ppm). Otherwise, no clear indication of toxicity was observed. There were slight effects on liver and kidney weight which may have been incidental.

The main study was compliant with OECD testing guideline 407 (adopted May 12, 1981) and GLP (Ciba-Geigy 1993b). As such, it lacks investigation of the additional parameters requested in the most recent version (Dec 2008) of the testing guideline.

The substance was administered in the diet for 4 weeks at dietary concentrations of 0, 40, 600, 2400, and 12000 ppm to a total of 70 albino rats. In each dose group five animals per sex and group (experimental group I) were sacrificed at the end of the treatment period. In the control group and in the highest dose group five animals per sex and group (experimental group II) were kept for a 4-week recovery period before sacrifice. Corrected for the analytically determined test article concentrations in the diet , the mean daily intake was 3.71, 50.7, 201 and 1075 mg/kg bodyweight in males, and 4.08, 56.9, 204 and 1141 mg/kg bodyweight in females. Red discolouration of feces due to the red test article was noted in groups 3, 4 and 5 (600, 2400 and 12000 ppm). No deaths occurred in this study. The bodyweight development was not affected by treatment. The mean food consumption of treated groups was essentially comparable to that of the control groups. The treatment had no influence on the hematological profile and there was no effect on blood chemistry, urinalysis, organ weights and pathology. The No-observed effect level was the highest tested dose of 12000 ppm.

Experimental data on repeated dose dermal or inhalation toxicity is not available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for repeated dose oral toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated dose oral toxicity under Regulation (EC) No. 1272/2008.