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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.