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Description of key information

The acute oral toxicity of Decyltrimethoxysilane was evaluated during a GLP-compliant study performed according to the OECD Testing Guideline 423. Three male and female rats received 2,000 mg/kg bw of test substance and were subsequently observed for 14 days. No mortality was observed and only transient clinical effects were reported in female rats. Based on these results and the flowchart described in the OECD Testing Guideline 423 it can be concluded that the substance has a LD50 greater than 2,500 mg/kg bw.

 

This result is supported by the outcome by an acute oral toxicity study performed according to a method similar to the OECD Testing Guideline 401. It concluded that the substance had a LD50 greater than 5,000 mg/kg bw.

 

In accordance with Annex VII of REACH it is not required to investigate the acute toxicity of Decyltrimethoxysilane via the inhalation or dermal routes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 25 September 2000 to 12 October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately eight weeks
- Weight at study initiation: Males: 223 to 237g. Females: 226 to 245g.
- Fasting period before study: yes
- Housing: Groups of three (by sex) in solid-floor polypropylene cages
- Diet: Rat and Mouse Expanded Diet n°1 ad libitum (with the exception of fasting period)
- Water: Drinking water (source not specified)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h/12h
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.22 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: not specified
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
3 animals/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for 14 days. Bodyweights were recorded prior to dosing and then seven and 14 days after treatment.
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Hunched posture was commonly noted in female rats with incidents of pilo-erection. Animals recovered within two days after dosing.
No clinical signs were observed in male rats.
Body weight:
All animals showed expected gains in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.

0/6 animals died following an acute oral exposure to the test substance at 2,000 mg/kg bw. Based on the results and the flowchart described in the OECD Testing Guideline 423, it is considered that the test substance has a LD50 greater than 2,500 mg/kg bw.

Interpretation of results:
GHS criteria not met
Conclusions:
It is concluded that the test substance has a LD50 greater than 2,500 mg/kg bw. The substance does not meet the criteria for classification as toxic following an acute oral exposure in accordance with Regulation (EC) No.1272/2008.
Executive summary:

The acute oral toxicity of the test substance was evaluated during a GLP-compliant study performed according to the OECD Testing Guideline 423.

Three female and three male Sprague-Dawley rats received a single dose of 2,000 mg/kg bw of test substance by gavage and were subsequently observed for 14 days. Bodyweights were recorded. At the end of the observation period animals were sacrificed and a necropsy performed.

No animal died as a result of the treatment with 2,000 mg/kg bw of test substance. Some transient clinical effects were observed in female rats that disappeared within two days following the exposure to the substance. No findings were noted during the necropsy.

Based on these results and the flowchart detailed in the OECD Testing Guideline 423 it can be concluded that the test substance has a LD50 greater than 2,500 mg/kg bw.

It can be concluded that the test substance does not meet the criteria for classification according to Regulation (EC) No.1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw
Quality of whole database:
The study was GLP-compliant and performed according to the OECD Testing Guideline 423.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

It is concluded that the Decyltrimethoxysilane has a LD50 greater than 2,500 mg/kg bw following an exposure via the oral route. The substance does not meet the criteria for classification as acutely toxic in accordance with Regulation (EC) No.1272/2008.