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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:
weight of evidence
Study period:
5 June to 3 July 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study was conducted in accordance with an appropriate guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
other: Crl:CD (SD) IGS BR VAF/Plus
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc., USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 154.4 to 181.2g
- Fasting period before study: yes
- Housing: individually in wire mesh cages
- Diet (ad libitum): LabDiet 5002, PMI
- Water (ad libitum): municipal water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.81 to 22.09
- Humidity (%): 40 to 66
- Air changes (per hr): 14.5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 June 2008 To: 3 July 2008

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: not stated

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not stated
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency of weighing: day of dosing, weekly thereafter including the day of necropsy
- Necropsy of survivors performed: yes
Statistics:
Body weight was reported as groups means and standard deviations, computed by Provantis v6.5

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
All animals gained weight from study day 1 to 15.
Gross pathology:
No findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a study conducted according to an OECD test guideline and in compliance with GLP, administration of [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane to female rats at 2000 mg/kg bw did not result in any remarkable findings and the LD50 was considered to be greater than 2000 mg/kg bw.