Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study did not meet current requirements for repeated dermal toxicity testing, particularly in respect of the number and duration of exposures.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
3-Glycidoxypropyltrimethoxysilane (TMSPGE, CAS No.
2530-83-8)

Test animals

Species:
rabbit
Strain:
other: other
Sex:
male

Administration / exposure

Details on exposure:
Route of Administration: dermal
Duration of treatment / exposure:
Approximately 1.25 hours/day
Frequency of treatment:
Two days (W, F) for the first week, three days (M, W, F) for the second week, and two days (M, W) for the third week for a total of 7 applications over 17 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0 or 1 ml/kg
Basis:

Control animals:
yes
Details on study design:
Post-exposure period: Not applicable.

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 1 other: ml/kg bw
Sex:
male

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

There was no mortality or remarkable differences in body
weight or absolute/relative liver or kidney weights. 
Abnormal skin responses (desquamation, and fissures) were
noted on the test substance-treated rabbits.  No abnormal
skin responses were noted on the control animals.

Applicant's summary and conclusion

Conclusions:
The no-observed-effect-level (NOEL) for systemic effects was
determined to be greater than 1.0 mL/kg/application of the
test substance to rabbits under the conditions employed in
this study.