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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(no data on test substance purity, exposure period 20 h with occlusive dressing, 2 animals, no 72 h score, 50% test substance solution)
Principles of method if other than guideline:
BASF-test:
The test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions. Additionally, the substance was applied for 1, 5 and 15 minutes. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours, 5, 7 and 8 days after administration. Findings were graded as described in OECD test guideline 404.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)
EC Number:
278-150-3
EC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)
Cas Number:
75247-18-6
Molecular formula:
C47 H49 Cu N11 .3 C18 H30 O3 S
IUPAC Name:
Copper,N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyanine-C,C,C-trimethanaminato(2-)-κN29,κN30,κN31,κN32]-,dodecylbenzenesulfonate (1:3)
Details on test material:
Please refer to chapter confidential details on test material

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.99 kg and 3.08 kg (males)
- Diet: ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 50 % (in water)


Duration of treatment / exposure:
The test substance was applied for 1 min, 5 min, 15 min (short term) and 20 hours (long term).
Observation period:
8 days
Number of animals:
2 rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol / lutrol 50% in water
- Time after start of exposure: 1 min, 5 min, 15 min, 20 hours

SCORING SYSTEM: as described in OECD guideline 404 (the BASF-code from the raw data was converted into the OECD Draize scheme).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animals 1-2)
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: 20 h administration
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animals 1-2)
Time point:
other: 24 - 48 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 48 h and 5 days
Remarks on result:
other: 20 h administration; see table below for details
Irritant / corrosive response data:
The short exposure periods (1, 5 and 15 min) showed no corrosive potential of the test substance.
Other effects:
Blue substance remnants (until the end of the observation period) infered with the evaluation of erythema

Any other information on results incl. tables

Exposition:  20 h
Animal  Reading  Erythema Edema Comment
1 24 h 1 0 blue substance remnants
2 24 h 1 0 blue substance remnants
1 48 h 0 0 blue substance remnants; decreased food consumption
2 48 h 1 0 blotchy, blue substance remnants
1 5 d 0 0 substance remnants
2 5 d 0 0 substance remnants
1 7 d 0 0 substance remnants
2 7 d 0 0 substance remnants
1 8 d 0 0 substance remnants
2 8 d 0 0 substance remnants
mean 24 - 48 h 0.75 0.00  
Exposition:  15 min
Animal  Reading  Erythema Edema Comment
1 15 min 2 0 blotchy, blue substance remnants
2 15 min 2 0 blue substance remnants
1 24 h 0 0 substance remnants
2 24 h 1 0 blotchy, blue substance remnants
1 48 h 0 0 substance remnants
2 48 h 0 0 substance remnants
1 5 d 0 0 substance remnants
2 5 d 0 0 substance remnants
1 7 d 0 0 substance remnants
2 7 d 0 0 substance remnants
1 8 d 0 0 substance remnants
2 8 d 0 0 substance remnants
mean 24 - 48 h 0.25 0.00  
         
Exposition:  5 min
Animal  Reading  Erythema Edema Comment
1 5 min 1 0 blotchy, substance remnants
2 5 min 2 0 blotchy, substance remnants
1 24 h 0 0 substance remnants
2 24 h 0 0 blue substance remnants
1 48 h 0 0 substance remnants
2 48 h 0 0 substance remnants
1 5 d 0 0 substance remnants
2 5 d 0 0 substance remnants
1 7 d 0 0 substance remnants
2 7 d 0 0 substance remnants
1 8 d 0 0 substance remnants
2 8 d 0 0 substance remnants
mean 24 - 48 h 0.00 0.00  
Exposition:  1 min
Animal  Reading  Erythema Edema Comment
1 1 min 2 0 blotchy, blue substance remnants
2 1 min 0 0 blue substance remnants
1 24 h 0 0 blue substance remnants
2 24 h 0 0 blue substance remnants
1 48 h 0 0 substance remnants
2 48 h 0 0 substance remnants
1 5 d 0 0 substance remnants
2 5 d 0 0 substance remnants
1 7 d 0 0 substance remnants
2 7 d 0 0 substance remnants
1 8 d 0 0 substance remnants
2 8 d 0 0  
mean 24 - 48 h 0.00 0.00  

Applicant's summary and conclusion