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Toxicological information

Toxicity to reproduction

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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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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 animals)

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