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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study, tested with the source substance Zeolite, cuboidal, crystalline, synthetic, non fibrous. According to the ECHA Guidance Document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
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

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): Wessalith AP 400
- Framework: monoclinic
- Related CAS number: 1318-02-1
- chemical name: sodium-aluminiumsilicate
- Analytical purity: no data
- surface modified

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