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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
Study period:
21 Aug. - 04 Sep. 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Sident 9
- Analytical data after ignition: SiO2 >98% , Na20 <1%, Al2O3 <0.2%, Fe2O3 <0.03%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Borchen/Germany
- Age at study initiation: 9 wks (male), 10 wks (females)
- Weight at study initiation: 183 - 191 g (male), 141 - 152 g (female)
- Fasting period before study: 16 h before start
- Housing: single in Macrolon cages
- Water: ad libitum
- Acclimation period: >= 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 22.5
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous suspension with 1 % carboxymethyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 237 mg silica/mL suspension
- Amount of vehicle (if gavage): 21.5 mL/kg bw (including 5100 mg TS)
- Justification for choice of vehicle: suspending the test material and stabilising the suspension

MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg bw


Doses:
5110 mg/kg bw (237 mg/mL)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not relevant

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
no particular findings
Body weight:
normal weight gain
Gross pathology:
no particular findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met