4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 28 Feb 1996 to 13 March 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

EC Number:

260-350-7

EC Name:

4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Cas Number:

56706-10-6

Molecular formula:

C18H42O6S2Si2

IUPAC Name:

4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Constituent 2

Reference substance name:

S2

IUPAC Name:

S2

Test animals

Species:

rat

Strain:

other: HsdCpb:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Harlan-Winkelmann

- Age at study initiation: 7 wk (m), 8 wk (f)

- Weight at study initiation: 166-181 g (m), 135-149 g (f)

- Fasting period before study: 16 h

- Housing: 1/cage

- Diet (e.g. ad libitum): standard diet, ad libitum

- Water (e.g. ad libitum): drinking water, ad libitum

- Acclimation period: 5 days



ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20.5 - 22.0

- Humidity (%): 48-62

- Photoperiod (hrs dark / hrs light): 12/12



IN-LIFE DATES:

From: 1996-02-28 To: 1996-03-13

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE

- Concentration in vehicle: 215 mg/ml

- Amount of vehicle: 10 mg/kg bw

- Lot/batch no. (if required): 1545501

DOSAGE PREPARATION (if unusual):

"Aqueous solutions were prepared by shaking immediately before dosing". Presumably "aqueous" is incorrect in this statement.

Doses:

2150 mg/kg bw (male and female)

No. of animals per sex per dose:

5 (in dose groups)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: observations daily; bw days 0, 7, 14

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight.

Statistics:

Described only as limit test.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 150 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None reported.

Gross pathology:

No treatment-related effect detected.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity

Dose (mg/kg bw)	Mortality (# dead/total)			Number with evident toxicity (#/total)
	Male	Female	Combined	Male	Female	Combined
2150	0/5	0/5	0/10	0/5	0/5	0/10

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

From a reliable study conducted in compliance with the standard guideline and in accordance with GLP, no mortality or treatment-related effects were seen at 2150 mg/kg bw.