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Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
EC Number:
406-640-0
EC Name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
Cas Number:
136920-07-5
Molecular formula:
Not applicable. Average Molecular Weight: Example Tetra-amide C150H300N6O4 = 2252 g/mol Average Molecular Weight : Based on the average molecular weight of the di-tallow amine starting material (mwt = 509 g/mol) = 2256 g/mol
IUPAC Name:
2-[(2-{bis[(dioctadecylcarbamoyl)methyl]amino}ethyl)[(dioctadecylcarbamoyl)methyl]amino]-N,N-dioctadecylacetamide
Details on test material:
- Lot No.: T 75492/ST 1414/90, Part 1
- Physical state: solid, light beige; after heating at about 50°C: liquid, yellow
- Storage condition of test material: Refrigerator
- Date of manufacturing: 1990-10-10

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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

Results and discussion

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.

In vivo (non-LLNA)

Resultsopen allclose all
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..

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria