Registration Dossier
Registration Dossier
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EC number: 233-477-0 | CAS number: 10193-36-9
Toxicity to reproduction
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
- Reference substance name:
- Tetrahydroxysilane
- EC Number:
- 233-477-0
- EC Name:
- Tetrahydroxysilane
- Cas Number:
- 10193-36-9
- Molecular formula:
- H4O4Si
- IUPAC Name:
- silicic acid
- Test material form:
- solid
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
