Registration Dossier
Registration Dossier
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EC number: 272-271-5 | CAS number: 68784-75-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimisch 1
Additional information
Silicic acid (H2Si2O5), barium salt (1:1), lead-doped was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 30, 100 and 300 mg/kg/day. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for a total of 28 days). The females were exposed for 2 weeks prior to mating, during mating, duringpost-mating, and at least 4 days of lactation (for 41-47 days).
Formulation analysis showed that the formulations were prepared accurately and homogenously, and were stable for at least 6 hours at room temperature.
Reproductive/Developmental results:
No reproductive/developmental toxicity was observedat any dose level.
Although only two females at 300 mg/kg/day survived to deliver live offspring due to the high mortality incidence, it could be concluded from the available data that no treatment-related effect on reproductive/developmental parameters occurred at 300 mg/kg/day. The lower gestation index and number of living pups at first litter check at 300 mg/kg/daywere ascribed to parental mortality, and were therefore not indicative of primary developmental toxicity.
Based on these results, the following No Observed Adverse Effect Levels (NOAEL) were derived:
Parental NOAEL: 30 mg/kg/day
Reproductive NOAEL: >=300 mg/kg/day
Developmental NOAEL: >=300 mg/kg/day
Justification for classification or non-classification
Based on the available data, Silicic acid (H2Si2O5), barium salt (1:1), lead-doped, does not need to be classified for reproduction or developmental toxicity according to Directive 67/548/EC or the CLP Regulation. However, based on the current Annex listing, classification is required, see the specific chapter.
Additional information
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