Polysulfides, bis[3-(triethoxysilyl)propyl]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 23 June to 7 July 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

See below

Principles of method if other than guideline:

No guideline stated. Study conforms largely to OECD 402 with minor deviations as stated below.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH, Borchen, GERMANY
- Age at study initiation: 10-14 weeks (males); 10-11 weeks (females)
- Weight at study initiation: 224-304 g (males); 161-180 g (females)
- Fasting period before study: 16 h
- Housing: 1/ Macrolon type II cage
- Diet: standard ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h


IN-LIFE DATES: From: 1982-06-23 To: 1982-07-07

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: no details given
- % coverage: -
- Type of wrap if used: no details given

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no details given
- Time after start of exposure: -

TEST MATERIAL
- Amount(s) applied: 4.64 ml/kg bw (4983 mg/kg bw)
- Concentration (if solution): neat

VEHICLE
- none

Duration of exposure:

No details of removal of test material. Observation for 28 days following application.

Doses:

4983 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 28 days
- Frequency of observations and weighing: no details given on frequency of clinical observations. Apparently body weights were not recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: no details

Statistics:

None.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 983 mg/kg bw

Based on:

test mat.

Mortality:

No deaths recorded during 28 days observation.

Clinical signs:

other: No evidence of treatment-related toxicity, however no details were given of the extent of observations.

Gross pathology:

No treatment-related abnormalities reported.

Other findings:

Eschar, recorded in 8/10 animals, finally resolved on day 13. No further details are given.

Any other information on results incl. tables

No tabulated details of findings are given in this report.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable study conducted largely in a manner similar to the OECD Test Guideline 402 but without details about compliancy to GLP, no mortality or systemic effects was found in rats treated at 4983 mg/kg bw.