Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
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:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: 'the rabbits were produced locally'
- Age at study initiation: 3-5 months
- Weight at study initiation: mean 2.5 kg
- Diet: 'Rockland rabbit ration'

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk

No further detail included in the test report.
Duration of exposure:
24h
Doses:
10 and 5 ml/kg
No. of animals per sex per dose:
5 males
Control animals:
not specified
Details on study design:
No details given in this very brief summary.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
6.3 mL/kg bw
Remarks on result:
other: Equivalent to 6741 mg/kg (calculated with density of 1.07 g/cm3)
Mortality:
Deaths occurred on the first and second day after application.
Clinical signs:
Three rabbits had convulsions on the first and second day after application.
Body weight:
No details given in this very brief summary.
Gross pathology:
Hemorrhage and congestion of the lungs, pale mottled livers with prominent acini, pale spleens, and pale mottled kidneys. Bloody discharge was present around the nose and mouth of two animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute dermal LD50 of 6.30 ml/kg bw (equivalent to 6741 mg/kg bw 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.