Registration Dossier

Administrative data

Description of key information

Subacute NOAEL (rat, male, female): 1000mg/kg bw (According to OECD 407) 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Subacute (28d) Repeated Dose Toxicity: Oral

The repeated dose toxicity of Pigment Red 254 (CAS# 84632-65-5) was evaluated in a short-term repeated dose toxicity study performed according to OECD guideline 407. Pigment Red 254 was administered orally (by gavage) for 28 days (high dose group:1000mg/kg bw) to five male rats and five female rats. Mortality (2 females, Day 17 resp. 20 of test) signs were not treatment related. Clinical signs (red discolored extremities) were observed in the animals of the high dose group (1000 mg/kg) starting with day 21. No changes of toxicological significance at termination of the treatment in haematogical or clinical chemistry. Gross pathology and histopatholgy changes were not treatment-related. From the results presented in this study, a NOAEL for subacute 28d oral toxicity for Pigment Red 254 was established at 1000 mg/kg/day.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Pigment Red 254 (CAS# 84632-65 -5) does not need to be classified for repeated dose toxicity when considering the criteria outlined in Annex VI of 67/548/EEC and does not need to be classified as specific target organ toxicity (repeated) when considering the criteria outlined inAnnex I of 1272/2008/EC.