Silicic acid, titanium salt

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic data given

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Principles of method if other than guideline:

Virgin female rats were mated with young adult males, and observation of the vaginal sperm plug was considered day 0 of gestation. Beginning on day 6 and continuing daily through day 15 of gestation, the females were dosed with the indicated dosages by oral intubation; the controls were sham treated with the vehicle. The controls were sham treated with the vehicle at the level equivalent to the group receiving the highest test dose. Body weights were recorded on days 0,6,11,15 and 17 of gestation. All animals were observed daily for appearance and behavior with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animals. On day20 all animals were subjected to caesarean section under surgical anesthesia, and the number of implantation sites, resorption sites, and live and dead fetuses were recorded. The body weight of live pups were also recorded. The urogenital tract of each dam was examined in detail for anatomical normality. All fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses of each litter underwent detailed visceral examinations employing 10x magnification. The remaining two-thirds were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

112926-00-8

EC Number:

601-214-2

Cas Number:

112926-00-8

IUPAC Name:

112926-00-8

Details on test material:

no data

Test animals

Species:

rat

Strain:

Wistar

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

exposure from day 6 to day 15 of gestation

Frequency of treatment:

daily

Duration of test:

20 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 13.5, 62.7, 292 and 1350 mg/kg bw
Basis:
no data

Control animals:

yes

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

>= 1 350 mg/kg bw/day (nominal)

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

>= 1 350 mg/kg bw/day (nominal)

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified