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Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2000

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
422-350-7
EC Name:
-
Cas Number:
5575-48-4
Molecular formula:
C13H30O3Si
IUPAC Name:
Decyltrimethoxysilane
Test material form:
liquid

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.