[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

EC Number:

248-573-8

EC Name:

[tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Cas Number:

27614-71-7

IUPAC Name:

27614-71-7

Details on test material:

- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Analytical purity: no data given
- Lot/batch No.: M200058
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS numbers are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff (R) K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +- 3 °C
- Humidity: 50 +- 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: sesame oil

Controls:

other: untreated shaved skin served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g test material, pasted with 0.4 ml sesame oil

Duration of treatment / exposure:

The exposure period was 4 hours.

Observation period:

72 hours after removal of the patches.

Number of animals:

3 females

Details on study design:

About 24 h before the start of the study the hair in the dorsal region of the body of the animals was removed with an electric clipper over an area of ca. 25 cm2. Only animals with intact skin were used.
Each animal was treated with the test material, the substance was evenly distributed over the whole surface of a 2.5 cm x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf AG). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 h, after the exposure all remnants of the test material were carefully removed from the skin with warm tap water.
Examinations of the skin took place 30 - 60 min as well as 24, 48 and 72 h after removal of the patches.
Erythema, eschar formation and edema were evaluated numerically, acc. to the score of Draize. All other changes of the skin were recorded.

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

Any other information on results incl. tables

No signs of irritations were observed during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information