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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea pig maximization test (GPMT) is already available for the registration outside of EU. Therefore, LLNA is not conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Intradermal injection induction : the 2.5% (w/v) concentration of test article was used
Topical induction : 50% (w/v) concentration of test article was used
Challenge exposure : 10% (w/v) concentration of test article was used
Challengeopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Intradermal injection induction : the 2.5% (w/v) concentration of test article was used
Topical induction : 50% (w/v) concentration of test article was used
Challenge exposure : 10% (w/v) concentration of test article was used
Details on study design:
Species: Mouse, CBA strain, inbred, SPF-Quality.
Recognized by the international guidelines as the recommended test system (e.g. OECD, EC, EPA).
Source: Charles River France, L'Arbresle Cedex, France
Number of animals: 20 females (nulliparous and non-pregnant), five females per group.


In the main study, three groups of five experimental animals were treated with test substance concentrations of 5%, 25% or 50% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Dimethyl sulphoxide).
Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index was subsequently calculated for each group.
Positive control substance(s):
yes
Remarks:
dimethyl sulphoxide

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5%
No. with + reactions:
2
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5%
No. with + reactions:
3
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Skin Examination Data
 Group Animal ID          Scores after challenge              Sensitization  
    24 hours 48 hours   (score > 1 within 48 hour)  
Control 3120041001 1 1
3120041002 0 0
3120041003 1 1
3120041004 0 0
  3120041005 0 0  
Treated 3120041006 2 3 Yes
3120041007 2 2 Yes
3120041008 3 2 Yes
3120041009 3 2 Yes
3120041010 3 2 Yes
3120041011 1 1 Yes
3120041012 1 1 Yes
3120041013 2 1 Yes
3120041014 3 3 Yes
3120041015 2 2 Yes
Sensitization rate (%) 80
Sensitization classification Strong sensitizer
           
―: not available

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
There were no systemic adverse effects including effects on clinical signs of toxicity and body weight observed in all animals. During the 48 hours after challenge exposure, eight of ten treated animals showed sensitive to the test article. The sensitization rate was 80%.
The substance is classified as a "strong sensitizer" as defined by the sensitization classification system.