Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 30 minutes. The hydrolysis products have been identified to be triethanolamine and zirconium dioxide. The discussion of toxicity is based on the hydrolysis/degradation products.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
chronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
The substance is a viscous liquid with viscosity over 25000 mPa.s at 25°C. Limited risk of inhalation. Animal testing cannot be justified
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 adverse effect observed
Dose descriptor:
NOAEL
250 mg/kg bw/day
Study duration:
chronic
Species:
rat

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No studies were conducted on the target substance, Tetrakis [[2,2',2"-nitrilotris[ethanolato]](1-)-N,O]zirconium. As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance, triethanolamine (TEA).

 

Dermal

Dermally, there were no signs of systemic toxicity in studies amongst rats and mice of up to 90 days duration with exposure levels up to 2000 mg/kg/day in rats and 4000 mg/kg/day in mice. There were signs of local irritation (mild hyperplasia) at approximately 125 mg/kg/day and above. Systemic NOAEL was set 250 mg/kg bw/day (rats).

 

Oral

For repeated oral exposure, the most reliable studies amongst rats and mice indicate that a NOAEL is of the order of 1000 mg/kg/day (for studies up to 90 days duration). Above this exposure level some signs of systemic toxicity are apparent, being manifested by unspecified changes to the liver and kidney. Administration by drinking water gave NOAELs of 2400 mg/kg/day or more amongst rats and mice in a 14 day study.

(OECD SIDS 1995)

Justification for classification or non-classification

Based on the NOAEL (oral), NOAEC (inhalation) and NOAEL (dermal) of triethanolamine, there is no need for classification of the target substance in accordance with the criteria of CLP Regulation.