Polysulfides, bis[3-(triethoxysilyl)propyl]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

during April and May 1977 (no further details)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

No guideline is indicated. The method described is similar to the (now deleted) OECD 401.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

EC Number:

915-673-4

Cas Number:

211519-85-6

Molecular formula:

For the substance, C18H42O6SnSi2 (n = 2 – 4) Constituent 1 (S2): C18H42O6S2Si2 Constituent 2 (S3): C18H42O6S3Si2 Constituent 3 (S4): C18H42O6S4Si2

IUPAC Name:

Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Test animals

Species:

rat

Strain:

other: Sprague Dawley outbred strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S. Ivanovas GmbH & Co, med. Versuchstierzuchten KG, Postfach 7, D-7964 Kißlegg/Allgäu, GERMANY
- Age at study initiation: 38 days (males), 42 days (females)
- Weight at study initiation: 100-105 g
- Fasting period before study: 15-16 h
- Housing: 1/Macrolon cage type II
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 0.5
- Humidity (%): 60 +/- 3
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated


IN-LIFE DATES: not stated - experimental work conducted during April and May 1977

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
none

MAXIMUM DOSE VOLUME APPLIED: 15.9 ml/kg bw

Doses:

10, 12.6, 15.9 ml/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 28 days
- Frequency of observations and weighing: frequency of clinical observations and body weight measurements not stated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15.9 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 17193 mg/kg bw based on relative density of 1.0813 at at 20C

Mortality:

No deaths in any group (see table 1).

Clinical signs:

other: No overt toxicity other than minor reduction in weight gain (see table 1).

Gross pathology:

No significant findings.

Other findings:

None.

Any other information on results incl. tables

Table 1: Number of animals dead or with evident toxicity

Dose (ml/kg bw)	Mortality (dead/total)			Reduced food intake (mean %)	Reduced body weight development (mean %)
	Male	Female	Combined	Days 1,2,7	Days 1,2,7
10	0/10	0/10	0/20	6,4,0	2,4,4,
12.6	0/10	0/10	0/20	10,2,0	4,4,6
15.9	0/10	0/10	0/20	11,4,6	2,0,4

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable acute oral toxicity study conducted according to a protocol similar to the now deleted OECD Test Guideline 401 but pre-dating GLP, an LD50 was concluded to be in excess of 15.9 ml/kg bw in male and female rats (equivalent to 17193 mg/kg bw based on relative density of 1.0813 at 20°C).