Silicic acid, aluminum calcium sodium salt

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

toxicity to reproduction

Data waiving:

other justification

Justification for data waiving:

other:

Reproductive effects observed:

not specified

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

This study was waived, it is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.

Short description of key information:
This study was waived in accordance with column 2 of REACH X (required for section 8.7.3) of REACH Regulation 1907/2006: no additional study indicated, based on the low toxicological activity of the substance, the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. It is therefore not justified to conduct animal testing.

Justification for selection of Effect on fertility via oral route:
It is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.

Justification for selection of Effect on fertility via inhalation route:
It is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.

Justification for selection of Effect on fertility via dermal route:
It is not justified to conduct further animal testing based on the low toxicological activity of the substance and the lack of systemic absorption via relative routes of exposure and the natural abundance of silicates. This is in accordance with REACH Annex X, Column 2.

Effects on developmental toxicity

Description of key information

A developmental toxicity / teratogenicity study was conducted on pregnant rats, mice, rabbits and hamsters. The results consistantly gave a maternal toxicity and a teratogenicity NOAEL of 1600 mg/kg bw/day.

Link to relevant study records

Reference

Endpoint:

developmental toxicity

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study was conducted using OECD Testing Guideline 414 and meets generally accepted scientific standards. Basic data given (e.g. results tables are provided), considered acceptable for assessment. Read-across from the results on the test substance has been made to the registered substance based on the similar structure of the two substances.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

not specified

GLP compliance:

no

Limit test:

no

Species:

hamster, Syrian

Strain:

other: (outbred)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no
- Housing: single
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: water suspension

VEHICLE
- Justification for use and choice of vehicle (if other than water): used as dispersant
- Concentration in vehicle: maximum 1500 - 1600 mg NAS/6.4 ml water => 10 ml suspension/kg bw
- Amount of vehicle (if gavage): adjusted to the dose, from 1 ml water/kg bw to 6.4 ml water/kg bw

Analytical verification of doses or concentrations:

no

Details on mating procedure:

- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: no data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy

Duration of treatment / exposure:

From day 6 to day 10 of gestation

Frequency of treatment:

Once per day

Duration of test:

Day 14: sacrifice of dams by Caesarian section

Remarks:

Doses / Concentrations:
0 mg/kg bw/day
Basis:
nominal conc.

Remarks:

Doses / Concentrations:
16 mg/kg bw/day
Basis:
nominal conc.

Remarks:

Doses / Concentrations:
74.3 mg/kg bw/day
Basis:
nominal conc.

Remarks:

Doses / Concentrations:
345 mg/kg bw/day
Basis:
nominal conc.

Remarks:

Doses / Concentrations:
1600 mg/kg bw/day
Basis:
nominal conc.

No. of animals per sex per dose:

22 pregnant hamsters

Control animals:

yes, concurrent vehicle

other: Positive control receiving Aspirin, 250 mg/kg bw/day

Details on study design:

- Dose selection rationale: no data

Maternal examinations:

BODY WEIGHT: Yes
- Time schedule for examinations: gestation day 0, 6, 8, 10, and 14

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: no data

POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 14
- Organs examined: In particular urogenital tract

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes (neonatal pup weight)
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data

Fetal examinations:

- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 1/3 per litter
- Head examinations: No data

Statistics:

No data

Historical control data:

No data

Details on maternal toxic effects:

Maternal toxic effects:no effects

Dose descriptor:

NOAEL

Remarks:

(Maximum dose tested)

Effect level:

1 600 mg/kg bw/day

Based on:

no data

Basis for effect level:

other: maternal toxicity

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Dose descriptor:

NOAEL

Remarks:

(maximum dose tested)

Effect level:

1 600 mg/kg bw/day

Based on:

no data

Basis for effect level:

other: teratogenicity

Abnormalities:

not specified

Developmental effects observed:

not specified

The administration of up to 1600 mg/kg (body weight) of the test material to pregnant hamsters for 5 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft of skeletal tissues of the test groups did not differ from the number occuring spontaneously in the sham-treated controls.

Conclusions:

The NOAEL for both maternal toxicity and teratogenicity was 1600 mg/kg bw/day i.e. no dose related effects were seen at the maximum dose used in the test. The administration of up to 1600 mg/kg (body weight) of the test material to pregnant hamsters for 5 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.

Executive summary:

The developmental toxicity and teratogenicity of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 414. Doses of 0 - 1600 mg/kg bw/day were administered to pregnant female hamsters for 5 consecutive days via oral (gavage) exposure. The NOAEL for both maternal toxicity and teratogenicity was 1600 mg/kg bw/day i.e. no dose related effects were seen at the maximum dose used in the test. The administration of up to 1600 mg/kg (body weight) of the test material to pregnant hamsters for 5 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occuring spontaneously in the sham-treated controls. The substance is not considered to cause developmental or teratogenic effects in rats. The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 600 mg/kg bw/day

Species:

rat

Quality of whole database:

A developmental toxicity / teratogenicity study was conducted on pregnant rats, mice, rabbits and hamsters. The results consistantly gave a maternal toxicity and a teratogenicity NOAEL of 1600 mg/kg bw/day.

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

A developmental toxicity / teratogenicity study was conducted on pregnant rats, mice, rabbits and hamsters. The results consistantly gave a maternal toxicity and a teratogenicity NOAEL of 1600 mg/kg bw/day.

The tested substance was silicic acid, aluminium, sodium salt. The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance. The registered substance is not considered to be a developmental toxin or a teratogen.

Justification for selection of Effect on developmental toxicity: via oral route:
The chosen study was conducted in accordance with OECD Testing Guideline 414.