Registration Dossier
Registration Dossier
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EC number: 945-327-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mar.6-Aug.13, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- slightly lower starting body weights of animals as indicated
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The species and route of administration were those stated in the regulations, giving a valid model for the assessment of sensitisation.
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
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Aerosil R 8200, pyrogenic Cas 68909-20-6
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- from: Charles River Italia, Calco, Italy; ca. 5 weeks old, 232-248 kg, 5 animals/cage, feed: Mucedola 8GP17 and bottled drinking water ad libitum, 22 +/- 2 °C, 55 +/-15 % humidity, 12 h light/dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Remarks:
- also: Freund's complete adjuvant
- Concentration / amount:
- 20%
- Day(s)/duration:
- once (on day 1)
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- 48h (starting on day 8)
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- 24h (starting on day 22)
- No. of animals per dose:
- 20 test group
10 control group - Details on study design:
- on clipped skin
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- other:
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- Not tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- 0
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
At challenge with the test item no response was apparent in any animal of the test or control group. No reaction to the vehicle alone was observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No response to the test item at 50% concentration was apparent at challenge in any animal of the test and control groups.
These results indicate that the test item, Aerosil R 8200, does not elicit a sensitisation response
in the guinea pig, being there no reaction observed at challenge.
(classification : no category, signal word: no signal word required, hazard statement: no hazard statement required)
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