Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Additional information