Octanethioic acid, S-[3-(triethoxysilyl)propyl] ester, reaction products with 2-methyl-1,3-propanediol and 3-(triethoxysilyl)-1-propanethiol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Feb 2007 (Date of Project Protocol) - 11 Apr 2007 (Date of Report)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive 96/54 EEC B.1.tris.

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: EPA Health Effects Test Guidelines, OPPTS 870.1000 "Acute toxicity testing background", EPA 712-C-02-189

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

Colour: Light yellow

Specific details on test material used for the study:

Storage: at room temperature

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HsdRccHan: WIST rats

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen , Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 148-228g (step 1); 149-155g (step 2)
- Housing: the animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet: feeding ad libitum, Altromin 1324 (TPF)
- Water: free acces to tap water
- Acclimation period: adequate acclimatization period

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Test item was admistered in a single dose by gavage using an intubation cannula. The test item was administered at a volume of 10 mL/kg body weight.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Step 1: 3 females;
Step 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed prior to the administration and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Cageside observations included changes in the skin and fur, eyes and mucous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No treatment related effects were observed in any animal.

Gross pathology:

No treatment related effects were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an oral toxicity study performed according to OECD/EC guidelines and GLP principles, the substance was found to be of low oral toxicity (LD50 > 2000 mg/kg bw/day).