Nitrilotriacetic acid

Toxicity to reproduction

Administrative data

Endpoint:

two-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Early, but well documented, profound study meeting today standards (conducted by Procter & Gamble, USA)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1971

Materials and methods

Principles of method if other than guideline:

Method: Procter & Gamble, USA

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trilon A

IUPAC Name:

Trilon A

Constituent 2

Reference substance name:

Trisodium nitrilotriacetate

EC Number:

225-768-6

EC Name:

Trisodium nitrilotriacetate

Cas Number:

5064-31-3

IUPAC Name:

trisodium 2,2',2''-nitrilotriacetate

Test animals

Species:

rat

Strain:

other: Charles River CD

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Duration of treatment / exposure:

Exposure period: continuous for 2 generations
Premating exposure period (males): 8 weeks
Premating exposure period (females): 8 weeks

Frequency of treatment:

continuous from weaning

Doses / concentrations

Remarks:

Doses / Concentrations:
0.1 and 0.5% [ca. 50-75 and 250-375 mg/(kg*d)]
Basis:
nominal conc.

No. of animals per sex per dose:

20

Control animals:

yes, concurrent no treatment

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

>= 250 mg/kg bw/day

Sex:

male/female

Basis for effect level:

other: overall effects

Results: F1 generation

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

>= 250 mg/kg bw/day

Sex:

male/female

Basis for effect level:

other: overall effects

Results: F2 generation

Effect levels (F2)

Dose descriptor:

NOAEL

Generation:

F2

Effect level:

>= 250 mg/kg bw/day

Sex:

male/female

Basis for effect level:

other: overall effects

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

Na3.NTA.H20 was neither embryotoxic nor teratogenic and
maternally toxic at either dietary level.
At 0.5%, there was a slight trend towards lower food
consumption as compared with control and 0.1 %-group
(P<=0.05 for F1-males and F0-females), but no significant
difference in food efficiency (body weight gain per food
intake). Slight retardation of growth was observed in parent
generations (F0 + F1), but not for male F0 and female F1
(therefore: tendency).
Conception varied from 86 (F2, at 0.5%) to 97% (F1,at 0.5%)
[control: 92 - 95 %]: Therefore, NTA-treatment had no
significant influence on fecundity in both generations. 
At 0.5 % NTA, weaning weights were reduced in both sexes in
the 1st litter of F1 and F2, but not in the 2nd F1-litter
[Tab. 3].  Therefore, there is no but a slight trend towards
post-natal growth retardation.
In both generations, there were no significant differences
from the control in all reproductive indicators and the rate
of malformations and organ lesions.