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Description of key information

Administration of EDTMP under the conditions of this study (by gavage) resulted in neoplastic (osteosarcomas) and nonneoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance. 
The non-neoplastic effects (metaphyseal osteosclerosis) were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
15 mg/kg bw/day
Study duration:
chronic
Species:
rat

Additional information

In a well conducted study male and female SD rats were administered EDTMP by gavage, which resulted in neoplastic (osteosarcomas) and non neoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance.

The non neoplastic effects (metaphyseal osteosclerosis) that were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw)


Repeated dose toxicity: via oral route - systemic effects (target organ) other: bone

Justification for classification or non-classification

The data suggest that there is no need to classify for adverse effects following repeated exposures. The NOAEL was derived from a two year oral gavage study in rats, rather than a 90 day study, and the effects reported were not considered to warrant classification. 

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