Registration Dossier
Registration Dossier
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EC number: 915-037-6 | CAS number: -
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary source. Read-across to synthetic amorphous silica.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 958
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- on intact and abraded skin in 0.5 % CMC
- GLP compliance:
- no
- 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:
- Silicon dioxide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- on intact and abraded skin in 0.5 % CMC
- Duration of treatment / exposure:
- 3 wks
- Frequency of treatment:
- 18 h/d, 5 d/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5000, 10000 mg/(kg bw*d)
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 2
- Control animals:
- yes, concurrent vehicle
- Positive control:
- Cosmetic talc (10 g/(kg bw*d)
Examinations
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 10 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects clinical signs; mortality; body weight; gross pathology; organ weights; histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No evidence of systemic toxicity or of gross or microscopic pathology; no significant difference in dermal irritation between control and dose groups
Applicant's summary and conclusion
- Executive summary:
In a repeated dose toxicity study via dermal route (Cabot Inc. 1958, see also ECETOC 2006), pyrogenic Cab-O-Sil fluffy showed no evidence of systemic toxicity or of gross or microscopic pathology, and no significant difference in dermal irritation between control and dose groups.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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