1-Octadecanaminium,N,N-Dimethyl-N-Octadecyl-,(Sp-4-2)-[29h,31h-Phthalocyanine2-Sulfonato(3-)-N 29,N 30,N 31,N 32]Cuprate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with well documented report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: Powder
- Lot/batch No.: Mix 51785
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approximately 11 weeks
- Weight at study initiation: 1925-2162 grams
- Housing: individually in cages with perforated floors
- Diet (e.g. ad libitum): Pelleted standard LKK-20 rabbit maintenance diet approximately 100 g per day
- Water (e.g. ad libitum): free access to tap water diluted with decalcified water
- Acclimation period: At least five days under test conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3C
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent/ 12 hours dark



IN-LIFE DATES: From: April 5, 1989 To: April 8, 1989

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: moistened with water

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

3 Days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2x3 cm

- Type of wrap if used: Metalline patch mounted to Micropore tape and secured with elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was removed using a dry tissue and subsequently a tissue moistened with tapwater
- Time after start of exposure: Four hours


SCORING SYSTEM:

Erythema and Eschar Formation
No erytehma -0
Very slight erythema (barely perceptible) -1
Well defined erytehma-2
Moderate to sever erythema-3
Severe erytehma (beet redness) to slight eschar formation (injuries in depth)-4

Oedema Formation
No oedema-0
Very slight oedema (barely perceptible)-1
Slight oedema (edes of area well defined by definite raising)-.2
Moderate oedema (raised approximately 1 mm)-3
Severe oedema (raised more than 1 mm and extendign beyond area of expsoure)-4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: average at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

other:

Time point:

other: na

Score:

0

Remarks on result:

other: non-irritating

Irritant / corrosive response data:

The test material resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin. The average (24,48, and 72 hour) eryehtma and edema scores were 0.

Other effects:

Blue staining was observed on the treated skin and on the fur over the head and feet of the animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: EU

Conclusions:

The test material resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin. The average (24,48, and 72 hour) erythma and edema scores were 0. The test material is not classifed under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.

Executive summary:

Under the conditions of this study, the test material resulted in primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin. The average (24,48, and 72 hour) erythema and edema scores were 0. The test material is not classified under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.