Zeolite, silica rich, crystalline, synthetic, non-fibrous

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

oxo[(oxoalumanyl)oxy]alumane silanedione hydrate sodium

EC Number:

930-985-0

Cas Number:

1318-02-1

Molecular formula:

M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, and for Na is n=1; y can range from 2 to 222, and w is the number of water molecules typically between 4 and 40. The composition based on the metals present in the zeolite is typically: Na: 0 - 19.0%, Al: 0,3 - 19.0%, Si: 16.6 - 46.1% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 5%

IUPAC Name:

oxo[(oxoalumanyl)oxy]alumane silanedione hydrate sodium

Details on test material:

- Name of test material (as cited in study report): NSA-100
- Framework: orthorhombic
- Related CAS number: 1318-02-1
- Physical state: cream coloured granular solid
- Analytical purity: no data
- Lot/batch No.: 36
- Storage condition of test material: room temperature in the dark
- surface modified with Li

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Kent, UK
- Weight at study initiation: males: 200-214 g, females: 203-218 g
- Fasting period before study: overnight
- Housing: in groups of up to 5
- Diet and water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 48-61
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Suspension

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

Range finding study:
There were no deaths. Clinical signs of toxicity noted in females were hunched posture, diarrhoea, red/brown staining around the snout and mouth.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

One female was killed in extremis on day 6

Clinical signs:

other: The female, killed in extremis on day 6, showed hunched posture, lethargy, decreased respiratory rate, tiptoe gait, red/brown staining around the snout and mouth, ataxia, emaciation, ptosis, splayed gait, and body tremor on days 3 to 6 with additional sig

Gross pathology:

No abnormalities were observed at necropsy of animals killed at the end of the study. Haemorrhagic lungs, dark liver, dark kidneys and haemorrhage of the large and small intestines were noted at necropsy of the female killed in extremis on day 6.