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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:
February 6 - March 16, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed before adoption of LLNA 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: Mistubishi Kagaku-Foods Corporation

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

FORM AS APPLIED IN THE TEST (if different from that of starting material): Solution

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre de Production Animale
- Weight at study initiation: 317-441 g
- Diet (e.g. ad libitum): Guinea pig diet, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-35
- IN-LIFE DATES: From: February 6, 2006 To: March 16, 2006

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
1.56%
Day(s)/duration:
2 injections
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
3.125% test substance and 50% Freund's Complete Adjuvant in olive oil.
Day(s)/duration:
2 injections
Route:
intradermal
Vehicle:
other: Freund's Complete Adjuvant in saline solution
Concentration / amount:
50% FCA in saline solution
Day(s)/duration:
2 injections
Route:
epicutaneous, open
Vehicle:
olive oil
Concentration / amount:
60%, pre-treatment with sodium lauryl sulfate
Day(s)/duration:
1 dose
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
30% and 60%
Day(s)/duration:
24 hrs
No. of animals per dose:
8 females, 3 males in test group
3 females, 2 males in control group
Details on study design:
RANGE FINDING TESTS: For the pre-maximum non-irritant concentration test, 2 females were injected with 0.78-25% test substance in olive oil. They were then exposed to 7.5-60% test substance in paraffin oil. No necrosis was noted after the intradermal injection. No skin reaction was noted after the topical exposure.

For the maximum non-irritant concentration test, 3 males for induced by intradermal injection with the test substance in olive oil, and then topically with the test substance in paraffin oil. After 16 days, a challenge exposure was done by topical exposure under occlusive dressing at 7.5%-60% test sustance in paraffin oil. No skin reaction was observed. Therefore, 60% was chosen as the maximum dose for the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 0 and Day 7
- Test groups: 1
- Control group: Yes
- Frequency of applications: One intradermal injection on Day 0, and one topical application on Day 7.
- Concentrations: 1.56% test substance intradermally, 60% test substance topically with pre-treatment with sodium laurate

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 16 days after last induction
- Exposure period: 1 day
- Test groups: 1
- Control group: Yes
- Concentrations: 30 and 60% test substance.
- Evaluation (hr after challenge): 24 and 48 hrs.
Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
Historical controls

Results and discussion

Positive control results:
50-100% of animals were sensitized in the historical positive controls.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30%
No. with + reactions:
0
Total no. in group:
11
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30%
No. with + reactions:
0
Total no. in group:
11
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
60%
No. with + reactions:
0
Total no. in group:
11
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
60%
No. with + reactions:
0
Total no. in group:
11
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Key result
Group:
positive control
Remarks on result:
other: No details on results

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The test substance is not sensitising to skin.
Executive summary:

11 guinea pigs were tested for the skin sensitization of the test substance in the GPMT. 5 animals were used as controls. The test animals were intradermally injected with 1.56% test substance, and a week later topically exposed to 60% test substance. After 16 days, a challenge exposure was done topically with 30 and 60% test substance. No reaction was observed after the challenge exposure. The test substance is not sensitizing to skin.