Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

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

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.

Applicant's summary and conclusion