Registration Dossier
Registration Dossier
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EC number: 215-851-5 | CAS number: 1429-50-1
Carcinogenicity
Administrative data
Description of key information
Read across from a well conducted chronic gavage study (rel 2) rats were administered by gavage EDTMP-4Na (15, 50 and 333 (increased from 150 on day 329 of study)) for 94 -107 consecutive weeks. The results showed EDTMP
-4Na to be carcinogenic in Sprague-Dawley rats at a level of 50 mg/kg (bw) in males and at 150/333 mg/kg (bw) females. No treatment related effects of any description were observed at the low dose (15 mg/kg (bw) in either sex. (active acid).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 15 mg/kg bw/day
Justification for classification or non-classification
Based on the available information on sodium salt (4Na) of EDTMP (CAS 22036-77-7) no classification for carcinogenicity is proposed for the any of the substances being registered in the EDTMP category in accordance with Regulation (EC) No 1272/2008. Toxicological data are conclusive in some animals (rats) at high doses but not sufficient for classification in humans. Additional toxicological data and weight of evidence to justify this non-classification are reported in supporting document attached in Section 13.
Additional information
Read across from a well conducted chronic gavage study (rel 2) rats were administered by gavage EDTMP-4Na (15, 50 and 333 - increased from 150 on day 329 of study) for 94 -107 consecutive weeks. The results showed EDTMP-4Na to be carcinogenic in Sprague-Dawley rats at a level of 50 mg/kg (bw) in males and at 150/333 mg/kg (bw) females. No treatment related effects of any description were observed at the low dose (15 mg/kg (bw) in either sex. There were non neoplastic effects (metaphyseal osteosclerosis) that were considered to be treatment related at the mid and high dose female groups and high dose male group.
In a well conducted mouse study the test compound (35631) was administered by gavage to 340 B6C3F1 mice (85/sex/group) at dose levels of 15 and 75 mg/k/day for a period of at least 24 months. There was no treatment related evidence of carcinogenicity under the conditions of this study. However there were non neoplastic changes considered to be treatment related at both treatment levels for females (fibrous osteodystrophy and alkaline phosphatase) and at 75 mg/kg males based on effects seen with alkaline phosphatase.
In a well conducted two year oral gavage study rats were treated with a mixture of EDTMP (neutralised with sodium hydroxide)and NaF at dose levels 0, 15:1.139 NaF, 75:5.695 NaF, 150: 11.390 NaF. The development of osteoarcomas were seen in the 75:5.695 NaF and 150: 11.390 NaF dose groups. This study was disregarded for hazard conclusion purposes due to the co-administration with NaF.
Carcinogenicity: via oral route (target organ): other: bone
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