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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with OECD guideline 406 with acceptable deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
; additional observations of the skin reactions 24 h after 1st challenge as well as 24 h after rechallenge was made.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
When this test was perform, the OECD testing guideline for the LLNA did not yet exist.

Test material

Constituent 1
Reference substance name:
Tris(octadec-9-enylammonium) (trisulfonatophthalocyaninato)copper(II)
EC Number:
403-210-4
EC Name:
Tris(octadec-9-enylammonium) (trisulfonatophthalocyaninato)copper(II)
Cas Number:
108300-90-9
Molecular formula:
C32 H13 Cu N8 O9 S3 . 3 C18 H37 N . 3 H
Details on test material:
- Substance No.: 85/565
- Physical state: blue powder
- Analytical purity: 95 %
- Lot/batch No.: P. 1+2 / 1985
- Storage condition of test material: cooling

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White, Dunkin Hartley HOE DHPK
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: 252 - 307 g
- Housing: 5 animals per cage in makrolon cages, type IV
- Diet: Kliba 341.4 mm Kaninchen-Meerschweinchen-Haltungsdiät (Klingentalmühle, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, supplemented with 2 g ascorbic acid per 10 l water, ad libitum
- Acclimation period: at least 7 days before beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal induction: 5 % in aqua dest. / resp. in Freund´s adjuvant/aqua dest.
Epicutaneous induction: 60 % in aqua dest.
1. challenge: 60 % in aqua dest. (non-irritating concentration)
2. challenge: 60 % in aqua dest. (non-irritating concentration)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal induction: 5 % in aqua dest. / resp. in Freund´s adjuvant/aqua dest.
Epicutaneous induction: 60 % in aqua dest.
1. challenge: 60 % in aqua dest. (non-irritating concentration)
2. challenge: 60 % in aqua dest. (non-irritating concentration)
No. of animals per dose:
10 animals in each control group
20 animals in the test group
Details on study design:
RANGE FINDING TESTS:
Amount applied :
2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing. The animals were exposed to about 0 .15 g of the test substance formulation.
Exposure period :
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold .
Site of application :
- flank, respective on the same area
Number of test animals:
- 4 per test concentration
Readings :
- about 24 and 48 h after the beginning of application
Assessment of skin findings:
1. Erythema and eschar formation:
a) No erythema = 0
b) Very slight erythema (barely perceptible) = 1
c) Well-defined erythema = 2
d) Moderate to severe erythema = 3
e) Severe erythema (beet redness) to slight eschar formation ( injuries in depth) = 4
2. Edema formation
a) No edema = 0
b) Very slight edema (barely perceptible) = 1
c) Slight edema (edges of area well defined by definite raising) = 2
d) Moderate edema (raised approximately 1 mm) = 3
e) Severe edema (raised more than 1 mm and extending beyond the area of exposure) = 4

MAIN TEST:
Induction:
Intradermal induction:
- 6 intradermal injections in groups of two per animal
Injections for the test group :
A) front row : 2 injections each of 0 .1 ml Freunds adjuvant without test substance emulsified with water 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 Freunds adjuvant/water (1:1) with test substance
Injections for control groups 1 and 2:
- The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent .
Site of application :
- shoulder
Readings :
- 24 h after the beginning of application
Assessment of the skin findings:
- analogous to the pretest

Percutaneous induction :
- 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 animals were exposed to about 0 .3 g of the testsubstance formulation .
- The control animals were not treated since the distilled water used as formulating agent was not expected to influence the result of the study.
Duration of exposure :
- 48 hours
Site of application :
- shoulder, same area as in the case of the previous intradermal application
Readings :
- about 48 h after the beginning of application
Assessment of skin findings:
- analogous to the pretest

Challenge:
Test concentration : non-irritant concentration
First challenge about 14 days after percutaneous application, second challenge one week later .
Amount applied :
2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing.The animals were exposed to about 0 .15 g of the test substance formulation.
1st challenge :
- treatment of the test group and of control group 1 with the test substance formulation (control group 2 remained untreated)
2nd challenge :
- treatment of the test group and of control groups 1 and 2 with the test substance formulation
Duration of exposure :
- 24 hours
Site of application :
- intact clipped flank
After the challenges residues of the test substance were wiped off with ethanol resp. ethanol/water (1:1).
Readings :
- about 24, 48 and 72 h after the beginning of application
Assessment of skin findings :
- analogous to the pretest

EVALUATION
(Based on the criteria of Annex VI/II D of the Council Directive of July 29, 1983 for the 5th Amendment of the Directive 67/548 EEC (= 83/467 EEC) )
The number of animals sensitized is primarily taken into account in the evaluation. The control animals are used to rule out a substance-induced primary skin irritation.
The findings obtained 48 hours after application are taken into account for the determination of the sensitization rate.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: 1st control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
other: 1st control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
72
Group:
other: 1st control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60 % in aqua dest.
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
very slight (4/10) to well defined (6/10) erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: very slight (4/10) to well defined (6/10) erythema.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
other: 1st control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
other: 1st control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
72
Group:
other: 1st control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
other: 2nd control group
Dose level:
60 % in aqua dest.
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
well defined erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: 2nd control group. Dose level: 60 % in aqua dest.. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: well defined erythema.
Reading:
rechallenge
Hours after challenge:
48
Group:
other: 2nd control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: 2nd control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
72
Group:
other: 2nd control group
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: other: 2nd control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
60 % in aqua dest.
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
very slight erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
60 % in aqua dest.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information