Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study.

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 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

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:

- Test substance No.: 85/565
- Physical state: blue powder
- Analytical purity: 95 %
- Lot/batch No.: P. 1+2 / 1985

-Structure: see figure

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: males: ca. 2.33 kg; females: ca. 2.59 kg
- Housing: 1 animal per cage in stainless steel wire mesh cages
- Acclimation period: at least 8 days before the beginning of the study
- Diet: Kliba Labordiaet 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), ca. 130 g per animal per day
- Water: ca. 250 ml per animal per day
- Clipping of the fur: at least 15 h before the beginning of the study

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin sites of the same animal served as control

Amount / concentration applied:

ca. 0.5 g of a 50 % aqueous suspension of the test material

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males and 1 female

Details on study design:

A test patch (2.5 cm x 2.5 cm) is covered with an ca. 0.5 mm layer of the 50 % suspension and applied on the upper third of the back or flanks of the animals.
At the end of the exposure period, the treated sites are washed with lutrol and lutrol/water (1:1).
The readings are made 30-60 min after removal of the patch and 24, 48 and 72 h after beginning of the application.
If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Other effects:

No irritation of the skin was observed in all animals at any time point.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU