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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Remarks:
Read across data
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source

Data source

Reference
Reference Type:
publication
Title:
SIDS Initial Assessment Report For SIAM 17
Author:
OECD SIDS
Year:
2003
Bibliographic source:
OECD,SIDS,2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(3-(trimethoxysilyl)propyl)ethylenediamine
EC Number:
217-164-6
EC Name:
N-(3-(trimethoxysilyl)propyl)ethylenediamine
Cas Number:
1760-24-3
Molecular formula:
C8H22N2O3Si
IUPAC Name:
(2-Aminoethyl)(3-(trimethoxysilyl)propyl)amine
Test material form:
liquid
Specific details on test material used for the study:
Not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
Not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
Not specified
Details on mating procedure:
not specified
Duration of treatment / exposure:
39 days
Frequency of treatment:
Daily, 7 days per week for up to 39 days
Details on study schedule:
Not specified
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
25 mg/kg bw/day (actual dose received)
Dose / conc.:
125 mg/kg bw/day (actual dose received)
Dose / conc.:
500 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
Not specified
Control animals:
yes, concurrent vehicle
Details on study design:
Not specified
Positive control:
Not specified

Examinations

Parental animals: Observations and examinations:
The animals were observed twice daily (once daily on weekends) for mortality/viability
Oestrous cyclicity (parental animals):
Not specified
Sperm parameters (parental animals):
Not specified
Litter observations:
Not specified
Postmortem examinations (parental animals):
Not specified
Postmortem examinations (offspring):
Not specified
Statistics:
Data were analyzed by Bartlett's and Kolmogorov-Smirnov tests. Parametric data was tested by using ANOVA followed by Dunnett's test; Non-parametric data was analyzed by Kruskal-Wallis test followed by Wilcoxon test. Significance levels were either P<0.05 or P<0.01.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Endocrine findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
not specified

Details on results (P0)

Not specified

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
>= 500 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
food consumption and compound intake

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: F1 generation

General toxicity (F1)

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Increased nasal sounds, labored respiration or soft vocalization
Mortality / viability:
mortality observed, treatment-related
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Anogenital distance (AGD):
not specified
Nipple retention in male pups:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
not specified

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not specified

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not specified

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
>= 500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
clinical signs
mortality
body weight and weight gain
clinical biochemistry
urinalysis
organ weights and organ / body weight ratios

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
In an oral gavage study conducted, the NOAEL for N-(3-(trimethoxysilyl)propyl)ethylenediamine relating to repeated dose (parental systemic) effects and to reproductive toxicity was at least 500 mg/kg bw/day, as no significant adverse effects were observed up to the highest dose of 500 mg/kg bw/day tested in rats.
Executive summary:

A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test study was performed with test chemical (CAS: 1760-24-3) in sprague dawley rats. Test chemical wass dissolved in corn oil at the doses of 25, 125, 500 mg/kg bw/day. Two females in the 500 mg/kg/day group were sacrificed or found dead in moribund condition. Both of these deaths were attributed to dosing-related errors. Clinical signs attributed to test substance included increased nasal sounds, labored respiration or soft vocalization. These signs were not seen in the control and infrequently seen in either of the two lower dose groups. There was no test substancerelated effects on body weight, body weight gain or food consumption. Observations recorded at dosing indicate a dose-related resistance to dosing. No test substance-related effects were observed in any of the reproductive parameters evaluated. Two high dose (500 mg/kg/day) and one low dose (25 mg/kg/day) females that did not produce litters had positive evidence of copulation. Six of the eight eight surviving high dose group females produced litters that were similar in all respects to control litters. Based on the results of this reproductive/developmental screening study, the NOAEL for maternal systemic toxicity of AEAPTMS in the rat via the oral dosing was considered to be 500 mg/kg/day.