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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
See attached justification
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: Read Across Source
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
no guideline followed
Principles of method if other than guideline:
ADMINISTRATION / EXPOSURE
- Type: colony bred rats
- Strain: Swiss albino
- weight at study initiation: 100-120 g
- Type of exposure: single intratesticular or subcutaneous
injection.

- Duration of test/exposure: 7 days
- Vehicle: sterile distilled water
- Concentration in vehicle: not reported
- Total volume applied: 0.2 ml
- Doses: 0.08 mmole/kg bw
- Concentrations: not reported
- Control: sterile distilled water. For intratesticular
injection the right testis served as control and the left
testis received the test substance.

EXAMINATIONS:
- Morphology of testis
- Histology of testis
- Weight of testis
- Spermatozoa in the ductus deferens
GLP compliance:
no
Species:
rat
Strain:
Swiss
Sex:
male
Route of administration:
other: single intratesticular or subcutaneous injection.
Vehicle:
water
Duration of treatment / exposure:
7 days
Dose / conc.:
9.76 mg/kg bw (total dose)
Positive control:
Yes
Key result
Dose descriptor:
NOAEL
Effect level:
> 9.76 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
clinical signs
organ weights and organ / body weight ratios
histopathology: non-neoplastic
histopathology: neoplastic
Remarks on result:
not measured/tested
Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
9.76 mg/kg bw/day (actual dose received)

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydroxysilane
EC Number:
233-477-0
EC Name:
Tetrahydroxysilane
Cas Number:
10193-36-9
Molecular formula:
H4O4Si
IUPAC Name:
tetrahydroxysilane
Test material form:
solid

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
> 9.76 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
clinical signs
organ weights and organ / body weight ratios
histopathology: non-neoplastic
histopathology: neoplastic

Results: F1 generation

Effect levels (F1)

Remarks on result:
not measured/tested

Overall reproductive toxicity

Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
9.76 mg/kg bw/day (actual dose received)

Applicant's summary and conclusion