Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No data are available for the test substance.The structure-related compound Trilon A (CAS: 5064-31-3) was neither embryotoxic nor teratogenic and maternally toxic at either dietary level (dose level: 0.1 and 0.5% = about 50 and 250 mg/kg). Male and female Charles River CD rats were used for this 2-generation study. The NOAELs found were >= 250 mg/kg for the parents as well as for the F1- and F2-generation (Nolen et al., 1971).


Short description of key information:
Nolen et al. (1971) reported a two-generation study. Male and female rats were offered Trisodium nitrilotriacetate as daily concentrations of 0.1 and 0.5% (= about 50 - 75 and 250 - 375 mg/kg/d). The authors concluded, that the test substance treatment had no significant influence on fecundity in both generations.The NOAELs for the F2- and F1-generation as well as for the parental animals were >= 250 mg/kg bw/day.

Effects on developmental toxicity

Description of key information
Rabbits were offered once daily oral (gavage) concentrations of 2.5, 25, 100 and 250 mg/kg bw/d from day 7 through day 16 of pregnancy. The authors (Nolen et al, 1971) concluded, that the test substance was neither embryo- or maternally toxic nor teratogenic at any dietary level. The NOAELs for maternal toxicity and embryotoxicity were 250 mg/kg bw/day.
Additional information

No data are available for the test substance.

Trilon A (CAS: 5064-31-3) was tested. Charles River CD rats were offered Trilon A in concentrations of 0.1 and 0.5% (= about 50 and 250 mg/kg) from day 6 – 15 of pregnancy. This substance was neither embrotoxic nor maternally toxic nor teratogenic at both dose levels. All of the defects were in the soft tissues and predominantly in the urinary tract: hydroureter and/or hydronephrosis comprised most of the anomalies observed. As there was no substance-related context, the authors assumed that it could have been caused by some virus. The NOAELs for maternal toxicity and teratogenicity were >= 250 mg/kg (Nolen, 1971).

 

New Zealand white rabbits were administered 2.5, 25, 100 or 250 mg/kg (aqueous solution, gavage). The test substance used was Trilon A (CAS: 5064-31-3). The study duration was day 7 – 16 of pregnancy. Trilon A was neither embryotoxic nor teratogenic at any dose levels. The NOAELs found were 250 mg/kg (for maternal toxicity and teratogenicity (Nolen, 1971).

 

Tjaelve (1972) reported a drinking water study using NMRI mice. Trilon A (CAS: 5064-31-3) was offered in a concentration of 0.2% (= about 300 – 350 mg/kg). The study lasted from day 6 – 18 of gestation. Trilon A exerted no significant embryotoxic effects and produced no increases in malformations though there was appreciable placental passage of radioactivity onto the fetus. The NOAEL for teratogenicity was found to be about 300 mg/kg.

 

Justification for classification or non-classification

Classification concerning reproductive toxicology/teraogenicity is not necessary.