Registration Dossier

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

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): 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.