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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

205-685-1

EC Name:

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

Cas Number:

147-14-8

Molecular formula:

C32H16CuN8

IUPAC Name:

copper polyphthalocyanine

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Batch no SF20927
- blue powder
- storage conditions: room temperature in the dark
- no data on purity available

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2 - 3.5kg
- Housing: individulally
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30-70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: June 1 2004 To: June 8 2004

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4h

Observation period:

24, 48 and 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure:4h

OBSERVATION TIME POINTS
24, 48 and 72 hours

SCORING SYSTEM: Draize
- Method of calculation: according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: reversibility is not applicable, as there were no findings.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48h

Any other information on results incl. tables

Skin Reaction	Observation Time		IndividualScores-Rabbit Numberand sex			Total
			104 Male	105 Male	106 Male
	1 Hour		1 STA	1 STA	1 STA	( 3 )
Erythema/Eschar	24 Hours		1 STA	1 STA	1 STA	3
Formation	48 Hours		O STA	O STA	O STA	( 0 )
	72 Hours		O STA	O STA	O STA	0
	1 Hour		0	0	0	( 0 )
Oedema Formation	24 Hours		0	0	0	0
	48 Hours		0	0	0	( 0 )
	72 Hours		0	0	0	0
Sum of 24 and 72-hour Readings (S)		:	3
Primary Irritation Index (S/6)		:	3/6=0.5

STA = Blue colored staining of the skin

(  ) =Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Copper phthalocyanine is not irritating to rabbit skin.