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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
chronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Three Generation Study With Indigo In Rats:
10 males and 20 females of each generation were dosed with 0, 0, 0, 5, 50, 150, 500 mg/kg bw/day of D&C Blue #6 and mated. The parent generation (F0) rats were bred twice, the F1b were bred thrice, and the F2b were bred once. The criteria of effect included the following indices: fertility, gestation, gestation survival, 4-/14-/21-day survival. Furthermore, the diet consumption and body weights of the parent rats and their progeny data were examined as were the number of resorption sites and corpora lutea at the 19-day kill of the third mating of half of the F1b dams. The differences between dosed and control groups were neither dose-related, nor progressive, nor were they indicative of mean or median values exceeding those of the controls. It is therefore concluded that only random, not deleterious effects were associated with the inclusion of indigo in the diet of rats for 3 generations.


Short description of key information:
No effects on reproduction process observed

Effects on developmental toxicity

Description of key information
No effects on intra-uterine development observed
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Teratogenicity Indigo Rat:
Groups of 20 pregnant female Charles River CD rats received suspensions of D&C Blue No. 6 by stomach tube at doses of 500, 160 and 50 mg/kg/day from day 6 through day 15 of gestation. Comparable groups received either the methylcellulose suspending vehicle as negative controls or aspirin, 250 mg/kg/day as positive controls. On day 20 of gestation Caesarean section was performed, the uterus examined and fetuses processed for subsequent examination for skeletal or visceral anomalies.
On the basis of numbers of viable and dead fetuses, resorption sites, mean fetal weight, distribution by sex, mean litter size, frequency of skeletal and visceral or structural anomalies; weight gain of pregnant females: Indigo was without effect on reproductive performance, maternal weight gain and fetal development.

Teratogenicity Indigo Rabbit:
Groups of 10 pregnant female New Zealand white rabbits received suspensions of D&C Blue No. 6 by stomach tube at doses of 500, 160 and 50 mg/kg/day from day 6 through day 18 of gestation. Comparable groups received either the methylcellulose suspending vehicle as negative controls or thalidomide at 100 mg/kg/day as positive controls. On day 29 of gestation Caesarean section was performed, the uterus examined and fetuses autopsied for detection of visceral anomalies. Subsequently, the eviscerated carcasses were processed for examination of skeletal anomalies.
On the basis of numbers of viable and dead fetuses, resorption sites, mean fetal weight, distribution by sex, mean litter size, frequency of skeletal and visceral or structural anomalies; weight gain of pregnant females: Indigo was without effect on reproductive performance, maternal weight gain and fetal development.

Justification for classification or non-classification

No effects on reproduction observed, no classification necessary