1-Butanamine, N-[3-(trimethoxysilyl)propyl]-, reaction products with (trimethoxysilyl)-N-[(trimethoxysilyl)propyl]-1-propanamine and 1,6-diisocyanatohexane homopolymer

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

iGloss Crosslinker (ZQ54-2211)

IUPAC Name:

iGloss Crosslinker (ZQ54-2211)

Details on test material:

- Name of test material (as cited in study report): iGloss Crosslinker (ZQ54-2211)
- Physical state: Liquid (highly viscous)/ yellowish, clear
- Analytical purity: Mn 1200 Da; Mw 1800 Da; PDI 1.5; Relative RI-area of compounds with M 250-500 Da: 1.7% and with M 250-1000 Da: 29.1%; determined with Gel Permeation Chromatography
- Lot/batch No.: 294222
- Storage condition of test material: Room temperature; no direct sunlight; protect against humidity
- Other: The test item was homogeneous by visual inspection.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 172 +/- 20%
- Fasting period before study: at least 16 hrs before test item administration
- Housing: single housing
- Diet: VRF1(P); SDS Special Diets Services ad libitum
- Water: Tap water ad libitum:
- Acclimation period: 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Remarks:

Ph.Eur.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Good homogeneity in olive oil Ph.Eur.

Doses:

2000 mg/kg (two times; limit test)

No. of animals per sex per dose:

3+3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed during clinical examination.

Gross pathology:

Conglomerate in the stomach in two animals of the first and in all animals of the second administration group was noted at necropsy on the last day of observation (six females).
Additionally dark spotted small intestine and white granular inclusion in the hypogastric region were observed in the one animal of the second administration group, which lost weight in the second post-exposure week.