Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report date:
1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
other: unclear
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane
EC Number:
222-217-1
EC Name:
2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane
Cas Number:
3388-04-3
Molecular formula:
C11H22O4Si
IUPAC Name:
trimethoxy[2-(7-oxabicyclo[4.1.0]hept-3-yl)ethyl]silane
Details on test material:
- Name of test material (as cited in study report): 3,4-epoxy cyclohexylethyl trimethoxysilane

Test animals

Species:
rat
Strain:
other: Carworth Farms-Elias
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: the laboratory in concern
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 90-120 grams
- Fasting period before study:

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Up to 1.9 ml or 0.96 ml per rat (to achieve 16 ml/kg or 8 ml/kg respectively)

Doses:
16 ml/kg, 8 ml/kg
No. of animals per sex per dose:
5 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
No details are given in this very brief summary.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
12.3 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to 13161 mg/kg (based on density of 1.07 g/cm3)
Mortality:
Most deaths occurred shortly after dosing (no further detail available).
Clinical signs:
The animals became prostrate soon after dosing.
Body weight:
No details are available.
Gross pathology:
Congested lungs, kidneys, stomachs, intestines and pale mottled livers with prominent acini.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral LD50 of 12.3 ml/kg bw (equivalent to approximately 13161 mg/kg based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP.