Registration Dossier
Registration Dossier
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EC number: 930-993-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1990-08-14 to 1990-08-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- IUPAC Name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Details on test material:
- - Name of test material (as cited in study report): Wessalith AP 400
- Related CAS number: 1318-02-1
- chemical name: sodium-aluminiumsilicate
- Analytical purity: no data
- surface modified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Temperature: 22 +/- 2°C
Rel. humidity: 55 +/- 15%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 5110 mg/kg bw (limit test)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Wessalith AP 400 (vehicle: aqueous carboxymethylcellulose suspension (1%) was administered at a single oral concentration of 5110 mg/kg bw (administration volume: 21.5 mL/kg bw) to 5 female and 5 male rats by gavage, respectively. Mortality was checked twice daily. The body weights were recorded at the beginning and also 7 and 14 days after administration. After 14 days observation period (post application) the animals were sacrificed and gross necropsy was performed on all animals.
- Statistics:
- Not applicable (no mortality occurred)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Mortality:
- Deaths did not occur.
- Clinical signs:
- other: There were no signs of toxicity observed.
- Gross pathology:
- No alterations were recorded.
- Other findings:
- No data.
Applicant's summary and conclusion
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