Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information
Administration of HC Blue No 2 (B037) to pregnant female Sprague-Dawley rats from days 6 to 19 post-coitum inclusive at 100, 300 and 1000 mg/kg bw/day caused blue colouration of urine and extremities in all females. In addition, blue coloured fur was observed in many females given 1000 mg/kg bw/day. Ptyalism was also observed in females given 300 and 1000 mg/kg bw/day.  Dosing at 1000 mg/kg bw/day caused maternal toxicity, shown by significantly lower body weight gains and food consumption, while there were no indications of any effects on the pregnancy parameters or embryo-fetal development. The NOAEL for maternal toxicity was 300 mg/kg bw/day and the NOEL for developmental toxicity was 1000 mg/kg bw/day.   
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 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

Justification for classification or non-classification