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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
Guinea Pig
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An in vivo study is available from the original notifier since the substance was notified under NONS.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hagemann GmbH & Co. KG, Extertal, D (strain: Pirbright White, Dunkin Hartley HOE DHPK [SPF-LAC) BÖ)
- Weight at study initiation: 283 - 354 g
- Housing: 5 per cage (Makrolon, type IV)
- Diet: Kliba 341 4 mm, Klingentalmuehle AG, Kaiseraugst, CH; ad libitum
- Water: tap water (about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week); ad libitum
- Acclimation period: At least 7 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
intradermal induction: 5% in olive oil
percutaneous induction: 50% in olive oil
challenge: 25% in olive oil
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
intradermal induction: 5% in olive oil
percutaneous induction: 50% in olive oil
challenge: 25% in olive oil
No. of animals per dose:
Test group: 10, control group: 5
Details on study design:
Pretest
For detecting a possible influence on irritating effects of previous intradermal treatment with Freund's adjuvant, animals pretreated with Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1) each, in the same manner as intradermal induction about 3 weeks prior to the application of the test substance were used. In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irritant concentratian was found to be a 50% test substance preparation in olive oil DAB 9 and the maximum non-irritant concentration a 25% test substance preparation in olive oil DAB 9 (48 hours after the beginning of application).
Applicability: it was possible to inject a 5% test substance preparation in olive oil DAB 9 resp. in Freund's adjuvant / 0.9%. aqueous NaCl-salution (1 :1) with a syringe.

INTRADERMAL induction: 13 intradermal injections in groups of two per animal
Injections for the test group:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 :1.
B) middle row: 2 injections each of 0.1 ml of the test substance formulation.
C) back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1) with test substance.
Injections for control groups 1 and 2: The animals were given the same injections but without test substance, only with the formulating agent.
Site of application: shoulder.
Readings: about 24 h and 48 h after the beginning of application.
Percutaneous induction was carried out one week after intradermal induction.
Amount applied: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing (the bandage consist of rubberized linenpatches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). In the case of liquids the filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance formulation. The control groups were treated analogously to the test group but only with the solvent without the test substance.
Duration of exposure: 48 hours. Site of application: shoulder, same area as in the case of the previous intradermal application. Readings: 48 h after the beginning of application.
Assessment of the skin findings: according to Draize, 1959 (analogous to the pretest)

CHALLENGE
Test concentration: maximum non-irritant concentration. Challenge 21 days after intradermal induction.
Amount applied: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing (the bandage consist of rubberized linenpatches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance formulation.
Challenge: 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 2 only received olive oil DAB 9.
Duration of exposure: 24 hours. Site of application: intact clipped flank. Readings: 24 and 48 h after the removal of the patch. Assessment of skin findings: according to Draize, 1959 (analogous to the pretest)
Positive control substance(s):
yes
Remarks:
1-chlor-2,4-dinitro-benzol
Positive control results:
Reading 24 hours after the challenge with 1% of the positive control substance in ethanol in postive skin reaction was observed in 10/10 tested animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 (olive oil only)
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 (olive oil only). No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25% in olive oil
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: 25% in olive oil. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 (olive oil only)
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 (olive oil only). No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% in olive oil
No. with + reactions:
6
Total no. in group:
9
Clinical observations:
6 out of 9 test animals showed very slight erythema.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in olive oil. No with. + reactions: 6.0. Total no. in groups: 9.0. Clinical observations: 6 out of 9 test animals showed very slight erythema..

One animal of the test group died after percutaneous induction.

Observation after intradermal induction:

Well-defined erythema and slight edema were observed at the injection sites of the control and test animals, at which only Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) was applied.

Injection of the test substance in olive oil DAB 9 resp. in Freund's adjuvant/0.9%/ aqueous NaCl-solution (1 :1) caused well-defined erythema and slight edema in the test animals. The control animals injected with olive oil DAB 9 (vehicle) showed well-defined erythema.

Observation after percutaneous induction:

Incrustation partially open (caused by the intradermal induction) in addition to well-defined erythema and slight edema were observed in the test and control animals.

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A guinea pig maximization test was performed comparable to OECD guideline 406 and according to GLP requirements (BASF AG 1991). 10 Dunkin Hartley guinea pigs were used in the treatment group and 5 test animals were used in the control groups (a second control group for a second challenge was not needed due to unambiguous results obtained in the first challenge). Based on a pretest, the following concentrations for induction and the challenge were selected:

Intradermal induction: 5% in olive oil DAB 9 or FCA

Percutaneous induction: 50% in olive oil DAB 9

Percutaneous Challenge: 25% in olive oil DAB 9

The following effects were observed: After intradermal induction well-defined erythema and slight edema were observed at the injection sites of the control and test animals, at which only Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) was applied. Injection of the test substance in olive oil DAB 9 resp. in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) caused well-defined derythema and slight edema in the test animals. The control animals injected with olive oil DAB 9 (vehicle) showed well-defined erythema. After percutaneous induction incrustation partially open (caused by the intradermal induction) in addition to well-defined erythema and slight edema were observed in the test and control animals.

After the challenge with the 25% test substance preparation in olive oil DAB 9 six out of nine test animals showed very slight erythema. The animals of control group 1 did not show any skin reactions. Olive oil DAB 9 applied as a vehicle did not cause any skin reactions neither in the test animals nor in the animals of control groups 1 and 2. Keroflux ES 3241 has therefore to be considered as skin sensitiser.


Migrated from Short description of key information:
Guinea Pig Maximization Test: sensitising (GLP, comp. to OECD 406; BASF AG 1991)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Following the conditions and results of the available test, substance has to be classified with R43 and "may cause allergic skin reaction" (Cat. 1) according to EEC/67/548 and Skin Sens. 1B, H317: May cause an allergic skin reaction according to the UN-GHS requirements respectively.