Silicon orthophosphate

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

Start: 15 Oct. 1962

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment, acceptable as screening method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Principles of method if other than guideline:

One-generation reproduction toxicity study with some deviations from the guideline: (number of animals and examinations to low (5 instead of 20 females), deficiencies in mating procedure (mating ratio 1:5 instead of 1:2, mating over 14 d, only 1 male used per treated and control group,) one (relatively low) dose only).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicon dioxide

EC Number:

231-545-4

EC Name:

Silicon dioxide

Cas Number:

7631-86-9

IUPAC Name:

dioxosilane

Details on test material:

- Name of test material (as cited in study report): Aerosil, not further specified, hydrophilic: CAS-Name: Silica, amorphous, fumed, crystalline free, CAS-No. 112945-52-5
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Details on mating procedure:

- M/F ratio per cage: 1:5

Duration of treatment / exposure:

Exposure period: 6 months
Premating exposure period (males): 4.5 months
Premating exposure period (females): 4.5 months
Duration of test: 6 months

Frequency of treatment:

daily

Details on study schedule:

Number of generation studies: 1

Doses / concentrations

Remarks:

Doses / Concentrations:
497 mg/kg bw/day (m); 509 mg/kg bw/day (f)
Basis:

No. of animals per sex per dose:

5 females
1 male per 5 females

Control animals:

yes

Examinations

Parental animals: Observations and examinations:

CAGE SIDE OBSERVATIONS: Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION: Yes

OTHER: Haematology on 5 animals of each group was conducted prior to exposure, each month and at the end of the study.

Litter observations:

PARAMETERS EXAMINED
- external appearance and development

Postmortem examinations (parental animals):

HISTOPATHOLOGY
On parental animals.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Details on results (P0)

OTHER FINDINGS (PARENTAL ANIMALS)
No haematological findings.

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

>= 497 mg/kg bw/day

Based on:

test mat.

Sex:

male

Basis for effect level:

other: NOAEL corresponding to the highest dose tested.

Results: F1 generation

Details on results (F1)

In pups during lactation [total: 45 and 37 (control), resp.], no behavioral or developmental or structural abnormalities were observed.

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

>= 497 mg/kg bw/day

Based on:

test mat.

Sex:

male

Basis for effect level:

other: NOAEL corresponding to the highest dose tested.

Overall reproductive toxicity

Reproductive effects observed:

not specified