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Toxicological information

Skin sensitisation

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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:
2012
Report date:
2012

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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform, surface-treated
Details on test material:
pyrogenic, Cas.-No.: 68909-20-6
Specific details on test material used for the study:
Aerosil R 8200

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:
48 h (starting on day 8)
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
50 %
Day(s)/duration:
24 h (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

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)
Executive summary:

The potential of Aerosil R 8200 to induce and elicit delayed dermal sensitisation was assessed in the guinea pig using the maximisation test of Magnusson and Kligman.