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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
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.
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
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
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)
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.
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.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Experimental data on the target substance is not available. The molecular weight of 656 - 870 is greater than 500 g/mol indicating the dermal penetration will be very low. The substance is not irritating to skin and will therefore not facilitate its own uptake into the stratum corneum.

No structural alert for protein binding was identified by the profilers OASIS and OECD in the OECD QSAR toolbox v3.3.0.152. (Q)SAR modelling using the software TIMES-SS predicted the substance to be non sensitizing, with the limitation that the structure is out of the applicability domain of the model.

 

Valid experimental data is available for the monosulfonic acid (CAS 28901-96-4) which represents the anionic part of the target substance and also part of the components of the target substance. CAS 28901-96-4 has a higher irritant potential to eyes and is of similar solubility in water. It was tested in a GLP compliant local lymph node assay in mice (OECD 429) and found to be non sensitizing. This study shows that the anionic part of the target substance is not skin sensitizing. Also the disodium salt of the disulfonated copperphthalocyanine (CAS 1330-38-7) is not sensitizing to skin as tested in a GLP-compliant guinea pig maximization test.

Valid experimental data is also available for the higher substituted analogue (CAS 108300-90-9). Instead of one sulfonate with an alkylamine counterion, it has three. Its alkylamine side chains contain one unsaturated C=C bond whereas the target substance has a saturated side chain. Both are non-branched. It is therefore of higher molecular weight which should result in a lower potential for skin permeation. A datamatrix with a more detailed read-across justification is provided as an attachment both in this Endpoint summary and to the Chemical safety report.

Migrated from Short description of key information:
The substance is considered to be non sensitizing in a weight-of-evidence approach based on (Q)SAR and valid experimental data on structural analogues.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available weight-of-evidence data are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available weight-of-evidence information is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC944/2013.