Phosphonic acid, P-(3-silylpropyl)-, Si,Si,Si-tris(mixed ethoxy and methoxy) derivs., mixed Et and Me diesters

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:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

diethyl [3-(trimethoxysilyl)propyl]phosphonate

EC Number:

619-721-2

Cas Number:

1079258-99-3

Molecular formula:

C8H21O6PSi - C13H31O6PSi, C14H35O9PSi2 - C17H41O9PSi2

IUPAC Name:

diethyl [3-(trimethoxysilyl)propyl]phosphonate

Details on test material:

- Name of test material (as cited in study report): Diethylphosphonatopropyltrimethoxysilan
- Physical state: liquid
- Analytical purity: GC column DB1 94.5 area-% and GC column RTX-5-Amine 92.4 area-% For details see analytical report No.: 14S00760.
- Lot/batch No.: 130011
- Expiration date of the lot/batch: October 23, 2015
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature

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, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
none

MAXIMUM DOSE VOLUME APPLIED: 1.84 mL/kg bw

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay. Individual body weights shortly 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, gross necropsy

Statistics:

Not required

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:

Impaired general state and piloerection was noted in all animals of the first 2000 mg/kg bw test group from hour 2 until hour 5 or study day 1, while dyspnoea and cowering position was observed from hour 2 until hour 3 or hour 4 after administration. In one of these animals reduced defecation was observed on study day 1 after administration only.
In the second 2000 mg/kg bw test group impaired general state and piloerection was noted in all animals from hour 3 until hour 5 after administration.

Body weight:

The body weight of all animals increased within the normal range throughout the study period with two exceptions in the second 2000 mg/kg bw test group.
In two animals the body weight increased within the normal range during the first week but stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).