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Diss Factsheets

Administrative data

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Cited as Directive 84/449/EEC, B.6
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: Pirbright White and Dunkin Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, D-W4923 Extertal 1, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 311-347 g
- Housing: 5 animals per cage (Makrolon, type IV)
- Diet: Kliba 341.4 mm (standardized diet), ad libitum
- Water: tap water ad libitum; about 2 g of ascorbic acid per10 L water was added to the drinking water twice a week
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C in fully air conditioned rooms
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Route:
other: intradermal and percutaneous
Vehicle:
olive oil
Concentration / amount:
intradermal induction: 5%
percutaneous induction: 50%
challenge: 25%
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
intradermal induction: 5%
percutaneous induction: 50%
challenge: 25%
No. of animals per dose:
5 animals in control group 1, 5 animals in control group 2, test group: 10 animals
Details on study design:
RANGE FINDING TESTS:
1 pretest was conducted using 4 animals per concentration. In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irrtitant concentration was found to be a 50 % test substance preparation in olive oil DAB 9 and the maximum nonirritant concentration a 25 % test substance preparation in olive oil DAB 9.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: single treatment
- Test groups: 6 intradermal injections (exposure 1) and 1 percutaneous induction (exposure 2)
- Control group: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent, and the same percutaneous induction but only with the solvent without the test substance.
- Site: shoulder
- Duration: duration of percutaneous exposure: 48 h
- Concentrations: Injections: test substance 5 % in olive oil DAB 9, resp. in Freund's adjuvant/0,9 % aqueous NaCl solution (1:1) resp. olive
oil DAB 9
Percutaneous induction: test substance 50 % in olive oil DAB 9

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Exposure period: 24 h
- Test groups: treatment of the test group and of control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle.
- Control group: Control group 2 only received olive oil DAB 9.
- Site: intact clipped flank
- Concentrations: test substance 25 % in olive oil DAB 9 resp. olive oil DAB 9
- Evaluation (hr after challenge): 24 and 48

Positive control substance(s):
yes
Remarks:
1-chlor-2,4-dinitro-benzol
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The test substance was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman. After the intradermal induction well-defined erythema and slight edema were observed at the injection sites of the control group animals and test group animals at which only Freund's adjuvant/0.9%/ aqueous NaCl-solution (1 :1) was applied. Injection of the test substance preparation in olive oil DAB 9 also caused well-defined erythema and slight edema in the test group animals. After applicatian of the test substance preparation in Freund's adjuvant/ 0.9% aqueous NaCl-salution (1 :1) necrotic skin changes and slight edema could be observed in the animals of the test group. The control group animals injected with olive oil DAB 9 (vehicle) exhibited well-defined erythema. After the percutaneous induction, necrotic skin changes partially open (caused by the intradermal induction) in addition to slight edema could be observed in the test group animals. The animals of the control groups, which were treated with olive oil DAB 9 showed incrustation partially open (caused by the intradermal induction) in addition to well-defined erythema and slight edema.

Based on the results of the study it was concluded that the test substance has a sensitizing effect on the skin of the guinea pig in the Maximization Test.


Migrated from Short description of key information:
Under the test conditions chosen the test substance has a sensitizing effect an the skin of the guinea pig in the Maximization Test.

Justification for selection of skin sensitisation endpoint:
guideline and GLP conform study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified for skin sensitisation into category 1 (H317: may cause an allergic skin reaction) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation No 605/2014.

Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified as R43 (May cause sensitisation by skin contact) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.