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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 2004 - Mar 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study initiated and performed before 2017.
Species:
guinea pig
Strain:
other: Himalayan spotted
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF stated
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 370-401 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions: Only animals without any visible signs of illness were used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
- IN-LIFE DATES: From: To:
Route:
intradermal
Vehicle:
water
Concentration / amount:
75 %
Day(s)/duration:
on day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.3 mL
Day(s)/duration:
on day 8, 48 hours duration
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25 %, 0.2 mL
Day(s)/duration:
day 22, 24 hours duration
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
intradermal pretest 1
epidermal pretest 2
control group 5
test group 10
positive control group 10 (study nr 849402)
Details on study design:
RANGE FINDING TESTS: one intradermal pretest and one epidermal pretest performed

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal day 1 epidermal day 8
- Test groups: 1 concentration
- Control group: physiological saline
- Site: scapular area
- Frequency of applications: once for each route
- Duration: intradermal - epidermal 48 h
- Concentrations: intradermal 75 %, epidermal 100 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: one test group
- Control group: water
- Site: left and right flank
- Concentrations: 25 % test substance in vehicle
- Evaluation (hr after challenge):

OTHER: Freund's complete adjuvant used during intradermal injection as well
Challenge controls:
purified water
Positive control substance(s):
yes
Positive control results:
All (at the 24-hour reading) and six (at the 48-hour reading) out of 10 test animals showed discrete/patchy erythema after the challenge treatment with Alpha-hexylcinnamaldehyde at 3 % (w/w) in PEG 300. NNo skin effect was observed in the control group.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 % (water)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0 % (water)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % test item
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25 % test item
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 % test item
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25 % test item
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
3 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs and no deaths occurred.
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
3%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs and no deaths occurred.
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the findings in an adjuvant sensitization test in guinea pigs, MG-60 does not have to be classified and labelled as a skin sensitzier. One out of 10 test animals showed skin reactions after the challenge treatment with MG-60 at 25 % (w/w) in purified water.
Executive summary:

In order to assess the cutaneous allergenic potential of MG-60, the Maximization-Test was performed in 15 (10 test and 5 control) female albino guinea pigs. A positive control study using 15 (10 positive control and 5 control) animals is reported as well.


The intradermal induction of sensitization in the test group was performed in the nuchal region with a 75 % dilution of the test item in purified water and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undiluted test item one week after the intradermal induction. The animals of the control group were intradermally induced with purified water under occlusion.


Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 25 % in purified water and pruified ater alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.


No toxic symptoms were evident in the guinea pigs of the control or test group.


No deaths occurred.


One our of 10 test animals showed skin reactions after the challenge treatment with MG-60 at 25 % (w/w) in purified water. No skin effect was observed in the control group.


The positive control substance proved to be a skin sensitiser (i.e. all test animals showed skin reactions after the challenge treatment).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available information is conclusive but not sufficient for classification