2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The result is sourced from secondary literature (company product literature-GE Advanced materials toxicology summary). The original reference was not available for review (and no further information is available).

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

To determine if there is potential for systemic toxicity following cumulative exposure to A-186.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

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): Silquest® A-186 Silane
No further information given.

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

19 days

Frequency of treatment:

Eight applications over 19 day period.

Doses / concentrations

Remarks:

Doses / Concentrations:
1.0 and 2.0 ml
Basis:
analytical per unit body weight

No. of animals per sex per dose:

Not stated

Control animals:

not specified

Results and discussion

Effect levels

Dose descriptor:

NOEL

Remarks:

Systemic NOEL

Effect level:

>= 1 other: ml/kg

Sex:

male

Basis for effect level:

other: Stated in report that severe scaling occurred in this dose group.However, no system effects were observed.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

None of the rabbits died, but there were significant body weight and kidney weight changes at the 2 ml/kg dosage level.  Severe scaling and minor erythema were noted at 2 ml/kg, with only severe scaling at 1.0 ml/kg. 

Applicant's summary and conclusion

Conclusions:

In a severely limited study summary the systemic NOEL following 8 dermal applications of Silquest® A-186 Silane was 1.0 ml/kg.

Executive summary:

To determine if the potential for systemic toxicity following cumulative exposure to A-186, two groups of male albino rabbits each received 8 inunctions of the clipped skin of the trunk over a 19-day period. Two dosage levels (1.0 and 2.0 ml/kg/inunction) were tested.  None of the rabbits died, but there were significant body weight and kidney weight changes at the 2 ml/kg dosage level.  Severe scaling and minor erythema were noted at 2 ml/kg, with only severe scaling at 1.0 ml/kg.  A no-observed-effect-level (NOEL) of 1.0 ml/kg was determined in this study.