Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992/11/06 to 1993/02/18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Old study, the report is not as detailed as would now be expected (for example test material details). Minor deficiencies such as bodyweight recordings missed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

other: LD50

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide

EC Number:

304-802-4

EC Name:

Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide

Cas Number:

94279-56-8

Molecular formula:

Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide

IUPAC Name:

Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Limited
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 106-207g
- Fasting period before study: overnight
- Housing: polypropylene cages with mesh floors
- Diet (e.g. ad libitum): ad libitum except for overnight before dosing and 4 hour after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 50
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: 1992/12/02 to 1993/02/18

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg (limit test)
1000, 1400, 1800, 2200 (LD50)

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to dosing, 7 days and at death or end of study (14 days)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology,

Statistics:

Finney (1971) and Berson (1953)

Results and discussion

Preliminary study:

4 out of 5 male rats and 3 out of 5 female rats died at 2000 mg/kg

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 387 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 529 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 372 mg/kg bw

Based on:

test mat.

Mortality:

Dose level (mg/kg)
1000 (0/5 male and 4/5 female)
1400 (3/5 male and 0/5 female)
1800 (5/5 male and 1/5 female)
2200 (5/5 male and 5/5 female)

Clinical signs:

other: noted 1 min to 3 days after dosing: piloerection, soiled coat, watery ocular discharge, subdued behaviour, prostration, tremors, hunched appearance, low body temperature, laboured breathing, increased salivation and activity, ataxia and pale extremities

Gross pathology:

In premature decedents only: these were confined to the mucosal surfaces of the stomach which were noted to be dark red in appearance. In additional and area of ulceration of the mucosal surface was observed in one animal.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The estimated LD50 is 1372 mg/kg bw for males and females

Executive summary:

Following a single orally administered dose of Frit (10 mL/kg in maize oil) at a dose level of 2000 mg/kg bw, 4 of the 5 male Sprague Dawley rats and 3 of the 5 female Sprague Dawley rats died. A further 4 dose levels of 1000, 1400, 1800 and 2200 mg/kg bw were selected to determine the LD50 value. In the LD50 test, deaths occurred 4h to 4 days after dosing.

Clinical signs, noted 1 min to 3 days after dosing, included piloerection, soiled coat, watery ocular discharge, subdued behaviour, prostration, tremors, hunched appearance, low body temperature, laboured breathing, increased salivation and activity, ataxia and pale extremities.

Necropsy findings, in premature decedents only, were confined to the mucosal surfaces of the stomach which were noted to be dark red in appearance. In additional and area of ulceration of the mucosal surface was observed in one animal.

The Median Oral Lethal Doses (LD50s) and 95% confidence intervals of Frit for male and female rats are estimated to be:

Males              1387 mg/kg

Females           1529 mg/kg

Males and Females       1372 (937 -1721) mg/kg

Note - no confidence intervals can be given for the male and female LD50 values due to the spread of the fractional mortality data