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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPFCpb)
Sex:
male/female
Details on test animals 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:
There were no signs of toxicity observed.
Body weight:
Body weight gain was within the expected range.
Gross pathology:
No alterations were recorded.
Other findings:
No data.

Applicant's summary and conclusion