Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

The oral toxicity of tetrahydrophthalic Anhydride (THPA) over an exposure period of 4 consecutive weeks and recovery from any potential treatment-related effects over a period of 2 consecutive weeks has been investigated. Methods were in accordance with OECD/EU test guidelines. No clinical signs of toxicity were observed and no significant variations were observed in haematology and clinical chemistry parameters. The high dose of 600 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for systemic toxicity and the low dose of 100 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for local effects.

 


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach

Justification for classification or non-classification

Those effects of treatment observed following repeated administration of the substance at high doses are not of sufficient severity to justify classification