Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dibutylstannane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February to march 2005

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

see free text

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

see free text

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: OPPTS 870.1000

Deviations:

yes

Remarks:

see free text

Principles of method if other than guideline:

There was the following deviation to the project protocol.
Concerning:
Administration, p 10 of the project protocol
Before:
Volume of administration: The test item will be administered according to bodyweight at a volume of 10mL/kg bw if technically possible.
New:
Volume of administration: The test item was administered according to bodyweight at a volume of 5 mL/kg bw.
Reason:
5 mL were used for administration as the test item was already soluble in 5mL. Due to animal welfare reasons, 5 mL were preferred as this smaller amount was less stress for the animals.

GLP compliance:

yes

Remarks:

Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dibutylstannane

EC Number:

300-344-4

EC Name:

Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dibutylstannane

Cas Number:

93925-42-9

Molecular formula:

C12H24O4Sn.C8H20O4Si

IUPAC Name:

Acetic acid, 1,1'-(dibutylstannylene) ester, reaction products with silicic acid (H4SiO4) tetra-Et ester

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Doses:

300, 2000 mg/kg bw

No. of animals per sex per dose:

3+3

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Results:

Sex	Dose (mg/kg)	Number of animals	Number of deaths
Female	300	3	1
Female	300	3	0
Female	2000	3	2
Female	2000	3	2

 

Signs of toxicity related to dose level used, time of onset and duration:

Animal No. 1 of step 3 (2000 mg/kg bw):

4 days post-dose slight reduced spontaneous activity, apathy, piloerection, weight reduction (140 g)

5 days post-dose slight reduced spontaneous activity, apathy, piloerection, weight reduction (139 g), abdominal respiration

6 days post-dose moderate reduced spontaneous activity, apathy, piloerection, weight reduction (134 g), abdominal respiration

7 days post-dose moderate reduced spontaneous activity, apathy, piloerection, weight reduction (128 g)

8 days post-dose death. (123 g)

Animal No. 2 of step 3 (2000 mg/kg bw):

4 days post-dose slight reduced spontaneous activity, apathy, piloerection, weight reduction (147 g)

5 days post-dose slight reduced spontaneous activity, half eyelid closure, apathy, piloerection, weight reduction (146 g), abdominal respiration

6 days post-dose moderate reduced spontaneous activity, half eyelid closure, apathy, piloerection, weight reduction (137 g), abdominal respiration

7 days post-dose death.

Animal No. 1 of step 4 (2000 mg/kg bw):

26.5 hours post-dose slight reduced spontaneous activity, apathy, labored respiratory, cyanosis at extremities and mucosa, piloerection27.5 hours post-dose moderate reduced spontaneous activity, abdominal position, apathy, labored respiratory, cyanosis at extremities and mucosa, piloerection

28 hours post-dose death

Animal No. 2 of step 4 (2000 mg/kg bw):

4 days post-dose slight reduced spontaneous activity, weight reduction (156g), piloerection

5 days post-dose slight reduced spontaneous activity, weight reduction (152g), piloerection, abdominal respiration

6 days post-dose slight reduced spontaneous activity, weight reduction (141g), piloerection

7 days post-dose slight reduced spontaneous activity, weight reduction (132g), piloerection

8 days post-dose slight reduced spontaneous activity, weight reduction (123g), piloerection

9 days post-dose weight reduction (130 g), piloerection

10 days post-dose (135 g), piloerection

11 days post-dose (143 g), piloerection

12 days post-dose (150 g), slight piloerection

13 days post-dose no signs of toxicity recorded

Animal No. 3 of step 4 (2000 mg/kg bw):

4 days post-dose slight reduced spontaneous activity, weight reduction (135g), piloerection

5 days post-dose slight reduced spontaneous activity, weight reduction (127g), piloerection, abdominal respiration

6 days post-dose slight reduced spontaneous activity, apathy, weight reduction (123 g), piloerection

7 days post-dose death, (118 g, piloerection)

No other treatment related clinical effects were observed in any animals of any steps.

Effect on organs (related to dose level):

Animal No. 3 of step 1 (300 mg/kg bw):

The animal died within the sixth night post-dose. The next morning necropsy was not possible, as due to cannibalism only residual parts without any organs of this animal were found.

Animal No. 1 of step 3 (2000 mg/kg bw):

Lateral recumbency, rough coat.

Animal No. 1 of step 4 (2000 mg/kg bw):

Abdominal position, opened mouth after death, liver notable dark colored (maybe congestion); right lung superior bloodinfiltrated.

Animal No. 3 of step 4 (2000 mg/kg bw):

Abdominal position, rough coat.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

According to GHS (Globally Harmonized Classification System) the test item Wacker Katalysator 41 was classified into Category 4 (LD50 cut-off: 1000 mg/kg bw).