Registration Dossier
Registration Dossier
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EC number: 930-915-9 | CAS number: 1318-02-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug. 9 - Nov. 16, 1990; experimental phase: Aug. 14-28, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- humidity was for a short period down to 35%, but without influence on the results of this study
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- EC Number:
- 930-915-9
- Cas Number:
- 1318-02-1
- Molecular formula:
- M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
- IUPAC Name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Test material form:
- solid: particulate/powder
- Remarks:
- no surface treatment
Constituent 1
- Specific details on test material used for the study:
- name: Wessalith AP 400 (A Zeolite)
appearance: white powder
batch no.: 89/100
solubility: insoluble in water
pH: appr. 10
purity: no known impurities
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- obtained from: Winkelmann Versuchstierzucht GmbH & Co. KG., Borchen, Germany
age: 8 - 9 weeks
body weight: 142-161 g (males), 129-137 g (females)
animals per cage: 1
feed: ssniff R ad libitum
water: tap water ad libitum
temperature: 21-22.5°C
humidity: 40-70%
light/dark: 12h / 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% tylose suspension (aqueous carboxymethylcellulose)
- Doses:
- 5110 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- 14 days of post examination
daily examination for clinical signs
body weights measured before application and on days 7 and 14
gross pathological examination of all animals
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 110 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- no mortlity
- Clinical signs:
- other: no signs of toxicity
- Gross pathology:
- no alternations were observed
Applicant's summary and conclusion
- Conclusions:
- Deaths did not occur. No alternations were recorded in gross pathological examination of the animals.
LD50 >= 5110 mg/kg - Executive summary:
Wessalith AP 400 was administered once orally to rats to determine its acute toxicity. The substance did not cause any signs of toxicity.
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