Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

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

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:
female

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
Positive control substance(s):
yes
Remarks:
α-hexylcinnamaldehyde

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
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):
other: Dimethyl Sulfoxide

Results and discussion

Positive control results:
The latest results showed that positive control animals had shown skin reactions of 1 and the sensitization rate of HCA was 80%.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
6
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: 6.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
9
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: 9.0. 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.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The SI values calculated for the substance concentrations 5, 25 and 50% were 9.4, 8.9 and 12.9 respectively. These results show that the test substance elicits an SI >= 3. The EC3 value was established to be between 0 and 5%.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: The DPM values calculated for the substance concentrations 5, 25 and 50% were 4038, 3835 and 5550 respectively.

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 3120040038 0 0
3120040039 1 1
3120040040 0 0
3120040041 0 0
  3120040042 0 1  
Treated 3120040043 1 1 No
3120040046 0 1 No
3120040048 1 1 No
3120040049 1 0 No
3120040050 0 1 No
3120040051 0 1 No
3120040054 1 1 No
3120040056 0 2 Yes
3120040058 1 1 No
3120040059 1 2 Yes
Sensitization rate (%) 20
Sensitization classification Mild 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, two of ten treated animals showed sensitive to the test article. The sensitization rate was 20%.
The substance is classified as a "mild sensitizer" as defined by the sensitization classification system.