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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

In a well conducted and reported, pre-GLP, dietary Combined Chronic Toxicity / Carcinogenicity study (Huntingdon Research Centre, 1979), conducted using a protocol similar to OECD 453, there was no evidence of neoplastic activity for Complexing Agent - Henkel (sodium salt of 1-hydroxythane-1,1-diphosphonic acid (disodium etidronate)) tested up to 384 and 493 mg/kg bw/day for males and females, respectively.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

This is the only reliable study available for HEDP or sodium/potassium salts of HEDP.

Justification for classification or non-classification

Based on the available carcinogenicity study sodium salt of HEDP does not require classification for carcinogenicity according to Regulation (EC) No 1272/2008.