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Diss Factsheets

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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
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:
According to Regulation 1907/2006, Annex VII, 8.3.2 a skin sensitisation study that was carried out or initiated before 10 May 2017, and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement.
The guinea pig maximisation test was performed according to OECD 406 and GLP in the year 2000 and is acceptable to fullfill the information requirements.

Test material

Constituent 1

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Remarks:
Ibm:GOHI; SPF synonym: Himalayan spotted
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Fuellinsdorf/ Switzerland
- Age at study initiation: 349 - 412 g
- Weight at study initiation: 4 - 6 weeks
- Housing: Individually
- Diet (e.g. ad libitum): Pelleted standard Nafag Ecosan 845 25W4, batch nos. 79/99 and 85/99, guinea pig breeding / maintenance diet, containing
Vitamin C ("Nafag", Naehr- und Futtermittel AG, Gossau), ad libitum
- Water (e.g. ad libitum): Community tap water from Fuellinsdorf, ad libitum
- Acclimation period: One week for the control and test group. No acclimatization for the animals of the pretest.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: PEG 400
Concentration / amount:
Intradermal injections: 3 %
Epidermal occl. patch induction: 50%
Challenge: 50%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: PEG 400
Concentration / amount:
Intradermal injections: 3 %
Epidermal occl. patch induction: 50%
Challenge: 50%
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TEST: To determine the different concentrations an intradermal and epidermal pretest was performed.
Intradermal injections: 1, 3, 5 %
Epidermal occl. patch induction: 10, 15, 25 and 50%
Challenge: 50%

MAIN STUDY
A. INDUCTION EXPOSURE
I.) INTRADERMAL INJECTIONS
- Test groups: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. 2) The test article, at 3 % in PEG 400. 3) The test article at 3 % in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. 2) PEG 400. 3) 1:1 (w/w) mixture of PEG 400 in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Site: area of dorsal skin from the scapular region
- Frequency of applications: Three pairs of intradermal injections given once

II.) EPIDERMAL APPLICATIONS
On test day 7 and approximately 24 hours prior to the epidermal application the scapular area (approximately 6 x 8 cm) of the animals of the control and test group was pretreated with 0.5 ml of 10 % Sodium-Lauryl-Sulfate (SLS) in paraffinum perliquidum as no primary irritation had been observed in the pretest. The SLS was massaged into the skin with a glass rod without bandaging. This 10 % concentration of SLS enhances sensitization by provoking a mild inflammatory reaction.
On test day 8, a 2 x 4 cm patch of filter paper was saturated with the test article (50 % in PEG 400) and placed over the injection sites of the test animals. The amount of test article preparation applied was approximately 0.3 g. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The occlusive dressings were left in place for 48 hours.
The guinea pigs of the control group were treated as described above with PEG 400 only, applied at a volume of approximately 0.3 ml.
The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.

B. CHALLENGE EXPOSURE
- Day(s) of challenge: The test and control guinea pigs were challenged two weeks after the epidermal induction application and were treated in the same way.
- Exposure period: 24 hours
- Site: left and right flank of each guinea pig
- Concentrations: The amount of test article preparation applied was approximately 0.2 g and a volume of approximately 0.2 ml was used for the vehicle
- Evaluation (hr after challenge): The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
Challenge controls:
yes, PEG 400
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole (CAS No. 149-30-4). Validation of assay indicated by frequent tests in the lab

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10 %
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not induce a sensitizing effect in guinea pigs after 24/48 h challenge.