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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
According to the secondary literature cited, the study was assigned reliability 2 (valid with restrictions; comparable to guidline study with acceptable restrictions).

Data source

Reference
Reference Type:
other: Collection of data from published literature and company data.
Title:
Unnamed
Year:
2004

Materials and methods

Principles of method if other than guideline:
Four animals per group used, two each treated on the intact and abraded skin: The substance was mixed with distilled water to form an aqueous
paste. Application to the intact and abraded skin under occlusive bandage. Observation period 14 d.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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:
ZEO 49, ZEOSYL 113, ZEOSYL 200, and ZEOFREE 153. Silica, precipitated, cryst.-free; CAS-No.: 112926-00-8.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
Four animals per group were used, two each treated on the intact and abraded skin: The substance was mixed with distilled water to form an aqueous paste. Application to the intact and abraded skin under occlusive bandage.
Duration of exposure:
Not specified.
Doses:
2000, 3000, 4000 and 5000 mg/kg
No. of animals per sex per dose:
Four animals per group were used, two each treated on the intact and abraded skin. Sex not specified.
Control animals:
not specified
Details on study design:
Four animals per group were used, two each treated on the intact and abraded skin: The substance was mixed with distilled water to form an aqueous
paste. Application to the intact and abraded skin under occlusive bandage.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths.
Clinical signs:
other: Local effect: very slight erythema (score 1 of 4), reversible after 2 days (ZEO 49), after 4 d (ZEOSYL) or 5 d (ZEOFREE) in one or a few animals.
Other findings:
No systemic signs of toxicity or organ toxicity.

Applicant's summary and conclusion

Conclusions:
LD50 >5000 mg/kg.
Executive summary:

An acute dermal toxicity study with precipitated synthetic amorphous silicon dioxide was carried out using rabbit as test organism. Four animals per group were used, two each treated on the intact and abraded skin. The substance was mixed with distilled water to form an aqueous paste and tested in four various doses (2000, 3000, 4000 and 5000 mg/kg). Application was done to the intact and abraded skin under occlusive bandage. The observation period covered 14 days.

Local effects such as very slight erythema (score 1 of 4) were observed which were reversible after 2 days

(ZEO 49), after 4 d (ZEOSYL) or 5 d (ZEOFREE) in one or a few animals. No systemic signs of toxicity or organ toxicity were documented.