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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (only summary report)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
addition of test substance to diet
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Synthetic amorphous aluminum sodium silicates [CAS No. 1344-00-9, not further specified]:

- Trade names:
Silteg AS 7
Silteg AS 9
Aluminiumsilikat P 820 (Sipernat 820 A) (analytical data after ignition: SiO2 82%; Al 9.5% as Al2O3; Na 8% as Na2O)
Sipernat 850 (analytical data after ignition: SiO2 66%; Al 26% as Al2O3; Na 7% as Na2O)
Transpafill (analytical data after ignition: SiO2 66%; Al 26% as Al2O3; Na 7% as Na2O)
Pasilex (analytical data after ignition: SiO2 82%; Al 9.5% as Al2O3; Na 8% as Na2O)
- Substance type: inorganic
- Physical state: solid
Note: >40 silica types included, amorphous, fumed and precipitated

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TNO
- Age at study initiation: "young adult"
- Weight at study initiation: 116 - 328 g (males); 78 - 160 g (female)
- Fasting period before study: no
- Housing: 1/cage during dose feeding, 5/cage the remainder of the study
- Diet: defined supplemented amount at dosing, ad libitum with unsupplemented stock diet
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +-1°C
- Humidity (%): no data
- Air changes (per hr): "well ventilated"
- Photoperiod (hrs dark / hrs light): no data


Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: diet
Details on oral exposure:
VEHICLE (Feed):
- Concentration in vehicle: 20 % (1:4, w/w)
- Justification for choice of vehicle: In the diet, higher dosing was possible, due to the voluminous character of the test material.



Doses:
approx. 10 g/kg bw over 24 hours
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: regularly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
10 000 mg/kg bw
Mortality:
none
Clinical signs:
no particular findings
Body weight:
no particular findings
Gross pathology:
no particular findings

Any other information on results incl. tables

Most animals consumed the supplemented diet quantitatively. No clinical symptoms or other pathological findings
following autopsy. No diarrhea, stool changed colour to grey, but showed normal consistency with faecal pellets
considerably bigger than normal. 

   

Applicant's summary and conclusion

Interpretation of results:
other: non-toxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
no classification (EU + GHS)