Reaction mass of Silicic acid, calcium salt and Silicic acid, magnesium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Report from year 1990.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

In the reference OECD SIDS (2004), the study was assigned realibility 1 (valid without restriction).

Data source

Reference

Reference Type:

other: Collection of data from published literature and company data.

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

other: Not specified (OECD SIDS, 2004).

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Silicon dioxide

EC Number:

231-545-4

EC Name:

Silicon dioxide

Cas Number:

7631-86-9

Molecular formula:

O2Si

IUPAC Name:

Silicon dioxide

Test material form:

solid

Specific details on test material used for the study:

Sident 9, >98% (SiO2), Na20 <1%, Al2O3 <0.2%, SO3 <0.8%, Fe2O3 <0.03%: CAS-Name: Silica, precipitated, cryst.-free; CAS-No.: 112926-00-
8.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The dose was applied as aqueous suspension (21.5 ml/kg bw = 237 mg silica/ml
suspension) containing 1 % CMC.

Doses:

21.5 ml/kg bw = 237 mg silica/ml suspension. Limit test: 5110 mg/kg

No. of animals per sex per dose:

Five male and 5 female animals were used.

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Based on:

not specified

Clinical signs:

other: No clinical symptoms or other findings.

Other findings:

No clinical symptoms or other findings.

Applicant's summary and conclusion

Conclusions:

Synthetic amorphous silicon dioxide (precipitated, CAS 112926-00-8) is considered as acutely non-toxic via oral exposure (LD50 > 5110 mg/kg bw using rat as test organism). No clinical symptoms or other findings were observed.

Executive summary:

An acute oral toxicity study with synthetic amorphous silicon dixoide (CAS 112926 -00 -8) was carried out with male and female Wistar rats. The study was done according to OECD Guideline 401 "Acute Oral Toxicity" under GLP conditions. The dose was applied by gavage as aqueous suspension (21.5 ml/kg bw = 237 mg silica/ml

suspension) containing 1 % CMC. The LD50 was found to be > 5110 mg/kg and no clinical symtoms or other findings were observed. In conclusion, Synthetic amorphous silicon dioxide is considered as acutely non-toxic (LD50 > 5110 mg/kg bw in rat following oral exposure).