Registration Dossier
Registration Dossier
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EC number: 912-631-7 | CAS number: 12022-95-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 09 - 19 Oct. 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Read-across to synthetic amorphous silica.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- IUPAC Name:
- dioxosilane
- Details on test material:
- 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
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Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Dose: 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The substance (0.5 g) was moistened with 0.5 ml of water and placed on a skin area of approx. 6.25 cm2.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0
- Irritant / corrosive response data:
- There were no irritating effects.
Any other information on results incl. tables
No signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No classification (EU and GHS)
- Executive summary:
Jahn and Berthold (1991) studied skin irritation of precipitated silica by moistening the substance (0.5 g) with 0.5 ml of water and placing it on a skin area of approximately 6.25 cm2. There were no irritating effects.
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