Registration Dossier

Administrative data

Description of key information

The repeated dose toxicity of Diacid 1550, the free acid of the target substance, was investigated in a combined 28-d repeated dose toxicity/reproscreening study that was performed in accordance with OECD 422 and under GLP conditions. Diacid 1550 was administered orally via the diet at 0, 500, 3000, and 15000 ppm. Based on increased liver weights and increased centrilobular hepatocyte hypertrophy in males and females at the highest dose, the parental NOAEL was considered to be 3000 ppm, corresponding to 271 mg/kg bw/day of free acid, under the conditions of this study. Considering the change in molecular weight of the potassium salt, this value becomes corrected to 298 mg/kg bw/d to be used for hazard and risk assessment of the target substance, the corresponding potassium salt.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
298 mg/kg bw/day
Study duration:
subacute
Species:
rat
System:
hepatobiliary
Organ:
liver

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

Based on the results of a subacute oral toxicity study resulting in effects only far above the threshold for classification, the substance is not subject for STOT RE (specific target organ toxicity, repeat exposure) according to CLP (Regulation EC No 1272/2008).