Registration Dossier
Registration Dossier
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EC number: 231-545-4 | CAS number: 7631-86-9
Acute Toxicity: dermal
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:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines of the Department of Transportation
- Principles of method if other than guideline:
- single dose level, 24h administration, 48h post observation
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Silica gel; CAS-No. 7631-86-9; EINECS-No. 231-545-4; BET: 340 - 390 m2/g
Constituent 1
- Specific details on test material used for the study:
- Syloid 244
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- obtained from: Skippack Breeding Farm; app. 3 kg, individually caged, feed: Purina rabbit chow
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- Application to the intact (5 rabbits) and abraded skin (5 rabbits) for 24 h
- Duration of exposure:
- 24 h
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- 10 in total
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 48h
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- No changes in skin condition were nited in any animal during the test period.
Any other information on results incl. tables
No erythema or edema occured. The skin irritation according to the Draize Scoring System was 0.0. (cf. attachement below)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As there was no mortality, the LD50 in the rabbit was greater 2 g/kg/bw. Also no skin irritation appered, the score (Draize) was 0.0.
- Executive summary:
The acute dermal toxicity if Syloid 244 was assessed in rabbits. Also its skin irritation potential was evaluated.
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