Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-8-20 to 1997-9-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The albino guinea-pig was chosen as the test species as it had been shown to be a suitable model for skin sensitisation studies and is the animal recommended in the test guideline. In addition, study completed prior to LLNA being adopted as an acceptable method.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 92480/J/17/1
- Expiration date of the lot/batch: Not supplied

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid: Diluted with Alembicol D depending on test

FORM AS APPLIED IN THE TEST (if different from that of starting material)
1% w/v in Alembicol D for the Induction intradermal injection
50% w/v in Alembicol D for the induction topical application
50% and 25% w/v in Alemvicol D for the topical challenge

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 300-381 g
- Housing: Groups of five in suspended metal cages with wire mesh floor. The control animals was seperate from the test animals. Hay was given weekly.
- Diet (e.g. ad libitum): Vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SOC) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-28.5
- Humidity (%): 39-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Alembicol D
Concentration / amount:
1% w/v
Day(s)/duration:
3
Adequacy of induction:
highest technically applicable concentration used
Route:
intradermal
Vehicle:
other: 50:50 mixture of Freund's complete adjuvant and Alembicol D.
Concentration / amount:
1% w/v
Day(s)/duration:
3
Adequacy of induction:
highest technically applicable concentration used
Route:
intradermal
Vehicle:
other: 50:50 mixture of Freund's complete adjuvant and Alembicol D
Remarks:
Alembicol D is a coconut derivative
Concentration / amount:
0% w/v
Day(s)/duration:
3
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
50% w/v
Day(s)/duration:
2
Adequacy of induction:
other: Highest technically applicable concentration and skin pre-treated with 10% SDS
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other: Alembicol D
Concentration / amount:
50% w/v
Day(s)/duration:
1
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, semiocclusive
Vehicle:
other: Alembicol D
Concentration / amount:
25% w/v
Day(s)/duration:
1
Adequacy of challenge:
not specified
No. of animals per dose:
15
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 exposure each with a different vehicle and/or concentration in a different location
- Exposure period: Not defined
- Test groups: Test animals 4000-4009
- Control group: Control animals 3995-3999
- Site: Anterior, Anterior and Posterior Repective to numbering below
- Frequency of applications: Once
- Concentrations:
Control animals:
(1) 0.1 ml of Freunds complete adjuvant 50 : 50 with water for irrigation (Wail,
(2) 0,1 ml of Alembicol D.
(3) 0.1 mi of Freunds complete adjuvant 50 : 50 with Alembicol D.
Test animals:
(1) 0.1 ml of Freund's complete adjuvant 50 : 50 with water för irrigation (Ph.Eur.),
(2) 0.1 mi of 11K-92,480% I % wtv in Alembiool D.
(3) 0.1 ml of UK-92,480 1% 1,viv in a 50 : 50 mixture of Alembicol D and Freund's complete adjuvant.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks
- Exposure period: 24 hours
- Test groups: Animals 4000-4009
- Control group: Animals 3995-3999
- Concentrations: 50% w/v in Alembicol D and 25% w/v in Alembicol D
- Site: Anterior and Posterior respectively
- Evaluation (hr after challenge): 24/48/72
Challenge controls:
Comparison to positive controls that used known irritants
Positive control substance(s):
yes
Remarks:
HCA & MBT

Results and discussion

Positive control results:
The postiive control showed the same results as the test animals.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% w/v in Alembicol D,
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd Reading
Hours after challenge:
72
Group:
test group
Dose level:
50% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% w/v in Alembicol D
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Slight erythema was observed in test animals following topical application
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd Reading
Hours after challenge:
72
Group:
test group
Dose level:
25% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd Reading
Hours after challenge:
72
Group:
negative control
Dose level:
25% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd Reading
Hours after challenge:
72
Group:
negative control
Dose level:
50% w/v in Alembicol D
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This test substance does not meet the criteria for this substance to be listed as a skin sensitizer per GHS criteria.