Registration Dossier

Administrative data

Description of key information

A LOAEL of 5 mg/kg/day was derived.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
LOAEL
5 mg/kg bw/day

Additional information

In a 2-year carcinogenicity study in which groups of 60 male and 60 female rats were fed diets containing TDCP to achieve dose levels of 0, 5, 20 and 80 mg/kg/day for 24 months, significantly greater mortality was recorded for high dose males. There was a clear adverse effect on body weight in the 80 mg/kg/day groups throughout the study, with body weights at termination >20 % lower than controls. A significant reduction in red blood cell parameters was noted for high-dose animals. Absolute and relative kidney, liver and thyroid weights were also increased in mid- and high-dose animals.

A LOAEL of 5 mg/kg/day (based on the hyperplasia, considered a pre-neoplastic lesion, observed in the kidneys in all treated groups and the testicular effects observed at this dose) can be derived from this study.

In a 90-day study to investigate the possible neurotoxicity of TDCP in hens, doses of 0. 4, 20 and 100 mg/kg/day TDCP were administered to hens. There were no mortalities in TDCP-treated birds. Under the conditions of the test, there was no evidence of TDCP induced delayed neurotoxicity. In an epidemiology study carried out in a TDCP manufacturing plant as an adjunct to a mortality study, no adverse health effects linked to TDCP exposure were determined.

No data are available on inhalation and dermal repeated dose toxicity.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; glandular: thyroids; urogenital: kidneys

Justification for classification or non-classification

The above data do not suggest to classify TDCP for repeated dose toxicity