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

Endpoint summary

Description of key information

Skin irritation/corrosion: non-irritating (GLP study according to OECD TG 404)

Eye irritation: non-irritating (pre-GLP study similar to OECD TG 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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

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

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

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.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48h

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

Interpretation of results:

GHS criteria not met

Conclusions:

Copper phthalocyanine is not irritating to rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

; 50 mm3 (one sharp-edged spoon) of test material applied (OECD0.1 ml,< 100 mg); 2 animals were used (OECD: 3); the eyes were not washed out after 24 h (OECD: washing after 24 h); observation period was 3 days (OECD: 2); exam. using fluorescein (OECD no)

Principles of method if other than guideline:

BASF-Test:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 µl or one sharp-edged spoon in case of solids of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted.

Specific details on test material used for the study:

- Analytical purity: 100 %

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Average weight at study initiation: ca. 3.0 kg
- Diet: Altromin-MS (Altrogge, Lage/L. Germany), ad libitum
- Water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

other: the second eye of the same rabbit was treated with 50 mg talcum powder.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: one sharp-edged spoon of the test substance, undiluted; ca. 50 mg

Duration of treatment / exposure:

24 h; the substance was not washed out

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

2

Details on study design:

One sharp-edged spoon of the undiluted, solid test substance was applied to the right conjuntival sac of one male and one female Vienna White rabbit. The left eye, treated with physiological saline, served as a control. The substance was not washed out.
Ocular reactions were recorded after 10 min, 1, 3 and 24 hours, as well as 2 and 3 days after instillation using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation the BASF scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours after application.

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 2 animals

Time point:

other: 24-48-72 h

Score:

0.16

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: finding was also seen in control eye

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 2 animals

Time point:

other: 24-48-72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 2 animals

Time point:

other: 24-48-72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 2 animals

Time point:

other: 24-48-72 h

Score:

0

Irritant / corrosive response data:

Slight conjunctivae redness as well as substance residues were observed in both eyes of all animals after 1 min, 1 hour and 3 hours of test substance instillation. In animal 1, no more findings were seen after 24 hours in both eyes. In animal 2, very slight conjunctivae chemosis was seen only in the left control eye after 1 and 3 hours and slight conjunctivae redness was still seen in both eyes after 24 hours. No more findings were seen after 48 hours in both eyes.

Table 1: Eye irritation parameters of 2 rabbits after application of the test material; scores were determined according to the method of Draize

Reading time point	Animal 1, treated eye (right)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0	substance residues
1 h	0	0	1	0	substance residues
3 h	0	0	1	0	substance residues
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Reading time point	Animal 1, control eye (left)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0	substance residues
1 h	0	0	1	0	substance residues
3 h	0	0	1	0	substance residues
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Reading time point	Animal 2, treated eye (right)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0	substance residues
1 h	0	0	1	0	substance residues
3 h	0	0	1	0	substance residues
24 h	0	0	1	0
48 h	0	0	0	0
72 h	0	0	0	0
Reading time point	Animal 2, control eye (left)
	Cornea	Iris	Conjunctivae redness	Conjunctivae chemosis	Additional findings
10 min	0	0	1	0	substance residues
1 h	0	0	1	1	substance residues
3 h	0	0	1	1	substance residues
24 h	0	0	1	0
48 h	0	0	0	0
72 h	0	0	0	0

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion:

In a skin irritation/corrosion study according to OECD guideline 404 and GLP, 0.5g of the test material, moistened with 0.5 ml of distilled water was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the clipped skin of 3 male New Zealand White rabbits. Four hours after application the patches and any residual test material were removed. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to Draize.

Very slight erythema was noted at all treated skin sites one hour after patch removal and at the 24-hour observation. No evidence of skin irritation was noted at the 48-hour observation. Therefore, it was concluded that the test substance is not irritating to rabbit skin.

Eye irritation:

A Draize test was performed with two New Zealand White rabbits, comparable to OECD guideline 405. Eyes were left unwashed after application of one sharp-edged spoon of the undiluted, solid test substance and were observed for 72 h. The mean score for conjunctivae redness was 0.16 in the treated eye, but was reversible within 72 h. In the control eyes, the mean conjunctivae redness score was also 0.16, reversible within 72 h. Scores for cornea, iris and chemosis were 0 at any reading time point in the treated eyes. It was concluded that the test substance is not irritating to the eyes.

 

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) 2018/1480.