Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study did not meet current guideline requirements. The study was not conducted in compliance with GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-trimethoxysilylpropane-1-thiol
EC Number:
224-588-5
EC Name:
3-trimethoxysilylpropane-1-thiol
Cas Number:
4420-74-0
Molecular formula:
C6H16O3SSi
IUPAC Name:
3-trimethoxysilylpropane-1-thiol
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
3 weeks, 19 days
Frequency of treatment:
8 inunctions: 3 during the first week, 3 the second week and 2 the third week.
Doses / concentrationsopen allclose all
Dose / conc.:
0.5 mg/kg bw/day (nominal)
Dose / conc.:
1 mg/kg bw/day (nominal)
Dose / conc.:
2 mg/kg bw/day (nominal)
No. of animals per sex per dose:
4 albino rabbits per dose
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
0.5 other: ml/kg
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Adverse skin responses were noted in all the test animals.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

All animals treated with 2.0 ml/kg died during the treatment period. Pale livers, kidneys and spleens were observed at necropsy. Congested lungs were also observed. One control animal treated with distilled water died during the treatment period. Severe diarrhoea was observed prior to death and was considered to be cause of death.

Statistically significant change in body weight was noted in animals treated with 2.0 ml/kg bw test material. Statistically significant change in body weight was observed in animals that received five doses of 1.0 ml/kg bw test material.

Marked erythema was observed after one dose of 2.0 ml/kg bw in all four animals. Large fissures and marked erythema were observed following the second dose. Desquamation was observed after application of two doses of 1.0 ml/kg bw test substance. The skin irritation increased to marked desquamation, erythema and small fissures after application of the third dose. These effects were observed throughout the study period with one rabbit developing spots of necrosis. Desquamation was noted after application of second dose of 0.5 ml/kg bw, which developed into marked desquamation, erythema and fissures after the third application. No abnormal skin responses were noted in any of the control animals that received distilled water.

Applicant's summary and conclusion

Conclusions:
In the 19-day repeated dose toxicity dermal study for 3-(trimethoxysilyl)propane-1-thiol, adverse skin reactions were reported at all dose levels and based on the available data the reviewer of this study report concludes a NOAEL for systemic toxicity of 0.5 ml/kg bw, but some of the observed effects could be secondary to the local dermal effects.