Registration Dossier

Diss Factsheets

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Key value for chemical safety assessment

Toxic effect type:

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
300 mg/kg bw/day
Study duration:
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