3-trimethoxysilylpropane-1-thiol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26th of July 2018 to 28th of August 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Adopted 17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No. 440/2008, L 142

Version / remarks:

Annex Part B, Method B.1, tris 30 May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

EPA 712-C-02-190, December 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-trimethoxysilylpropane-1-thiol

EC Number:

224-588-5

EC Name:

3-trimethoxysilylpropane-1-thiol

Cas Number:

4420-74-0

Molecular formula:

C6H16O3SSi

IUPAC Name:

3-trimethoxysilylpropane-1-thiol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 152-165 g
- Fasting period before study: 16-19 hours
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding.
- Diet: ad libitium of Altromin 1324 maintenance diet for rats and mice
- Water: ad libitum of free access to tap water, sulphur acidified to a pH value of approximately 2.8.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26 July 2018 To: 28 August 2018

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

300 mg/kg bw and 2000 mg/kg bw.

No. of animals per sex per dose:

3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighting on day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, pathology

Statistics:

With a few exceptions, data were captured using the validated departmental computerised system E-WorkBook (version 10.1.2, ID Business Solutions Ltd.).

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut off

Mortality:

At 2000 mg/kg bw, mortality occurred in two rats on day two and one rat was euthanised for ethical reasons. At 300 mg/kg bw, no mortality was observed.

Clinical signs:

other: At 2000 mg/kg bw, the test material caused clinical signs including reduced spontaneous activity, ataxia, moving of the bedding, sunken flanks, prone position, hunched posture, hypothermia, tremor and slow movements. At 300 mg/kg bw, the test material ca

Gross pathology:

At 2000 mg/kg bw, gazeous distension and dilated blood vessels were observed at necropsy. At 300 mg/kg bw, no specific gross pathological changes were recorded.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In an acute oral toxicity study with 3-trimethoxysilylpropane-1-thiol, conducted according to OECD TG 423 and in compliance with GLP, the concluded LD50 value was 500 mg/kg bw.

Executive summary:

In an acute oral toxicity study with 3-trimethoxysilylpropane-1-thiol, conducted according to OECD TG 423 and in compliance with GLP, the concluded LD50 value for female rats was 500 mg/kg bw based on severe signs of toxicity and mortality at 2000 mg/kg bw, and slight signs of toxicity but no mortality at 300 mg/kg bw.