Registration Dossier

Administrative data

Description of key information

The test item, HC Blue No 2, when administered daily by gavage to Sprague-Dawley rats at the dose level of 100, 300 or 1000 mg/kg bw/day for 13 weeks was well absorbed and caused purple colouration of urine and, as a consequence, of extremities and excessive salivation in all the treated animals. At 1000 mg/kg bw/day, higher absolute and relative liver and kidney weights were observed in both sexes at the end of the dosing period and the recovery period (except for kidneys in males) while no changes were noted on hematology or biochemistry parameters. Only relative liver increases in females given 1000 mg/kg bw/day were considered to be test item related adverse effects. No treatment related findings were noted at histopathological examination. After a 4 week treatment free period, coloured urine and excessive salivation were no longer observed while the slight increase in liver weights were still observed in females given 1000 mg/kg bw/day. Under the experimental conditions of the study the NOAEL of the test item was considered to be 300 mg/kg bw/day.   

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification