[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper

Endpoint summary

Description of key information

No skin irritation was observed in a test on rabbits similar to OECD TG 404 and GLP (BASF 1976).

No eye irritation was observed in a test on rabbits similar to OECD TG 405 (BASF 1976).

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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable study report

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

more stringent application regime, only 24 and 48 observations

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Body weight: 3.63 and 3.39 kg

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin of the animals

Amount / concentration applied:

About 1 g of a 50% aqueous test substance preparation

Duration of treatment / exposure:

20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

Application area: 2.5 x 2.5 cm
Application site: back
The test substance was not washed off.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: days 1, 2, 5, 7 and 8

Score:

0

Max. score:

0

Remarks on result:

other: blue test substance residues were seen on day 1.

Irritation parameter:

edema score

Basis:

mean

Time point:

other: days 1, 2, 5, 7 and 8

Score:

0

Max. score:

0

Interpretation of results:

GHS criteria not met

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

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP, deviations from guideline, design and details sufficient for hazard assessment.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Less observation time points, only 2 animals, 8 days observation

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the animal

Amount / concentration applied:

About 50 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

The test substance was not washed out.
On day eight, the eyes were investigated using fluorescein.

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 48h

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: day 1 - day 8

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: day - day 8

Score:

0

Max. score:

4

Irritant / corrosive response data:

After 1h, grade 2 (of max 4) of irritation and dark bluish substance residues were observed for the treated eyes. Grade 2 irritation was also observed at the 24h reading in one animal. It was no longer observed at 24 or 48h reading and no further effects were observed until the last investigation on day 8.

Other effects:

Body weight development:
Animal 1: Start 3.26 kg - end 3.19 kg
Animal 2: Start 3.14 - end 3.04

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 was tested in rabbits prior to the introduction of GLP and OECD testing guidelines (BASF 1976). The study is reported in sufficient detail for evaluation.

Twenty-four hours prior to dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two sites lateral to the midline of the back were used on each rabbit. Immediately before the application of the compound, the right hand side was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand side remained intact.

 

1g of the compound was applied in 50% aqueous suspension to both the abraded and intact test site on a 2.5cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made on days 1,2,5,7 and 8.

 

The test item caused blue staining of the test item on day 1. After that no local effects were seen. The 24h-occlusive exposure is more stringent than the 4h-semiocclusive treatment prescrirbed in OECD testing guideline 404. The substance does not react with air and is not volatile, so that the occlusive conditions have no influence on the outcome. The substance is therefore considered to be non irritating to skin.

Eye irritation was tested in rabbits prior to the introduction of GLP and OECD testing guidelines (BASF 1976). The study is reported in sufficient detail for evaluation.

The procedure is similar to OECD testing guideline 405. It differs in the shorter observation time of 8 days and in that only 2 animals (Vienna White rabbits) were used.

Ca 50 mg of the test item was applied into one eye of each rabbit without the use of a vehicle. Considering the relative density, this is likely to amount to a volume of 0.1ml as required by the OECD testing guidline. The untreated eye served as control.

The test substance was not washed out. A scoring system translatable to Draize Scores was applied. On day eight, the eyes were investigated using fluorescein.

 After 1h of application, grade 2 (of max 4) of irritation and dark bluish substance residues were observed for the treated eye of one animal. Grade 2 irritation (cornea and conjunctivae) was also observed at the 24h reading in one animal. Cornea findings were no longer observed at 24 and conjunctivae findings no longer at the 48h reading and no further effects were observed until the last investigation on day 8. No chemosis was observed at any time point. The second animal only showed signs of irritation at the 1h time point.

 

Therefore, the criteria for classification and labelling as an eye irritant (GHS criteria) are not fulfilled.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

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 thirteenth time in Regulation (EC) No. 2018/1480.