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

Endpoint summary

Description of key information

The pigment is considered to be non irritating to skin and eyes based on experimental data  in rabbits on copper phthalocyanine pigments and on the BfR skin and eye irritation rules.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A category assessment is performed, which is based on the hypothesis that the copper phthalocyanine pigments are too insoluble in water or fat / octanol to cause local effects. All pigments fulfill the BfR skin and eye exlusion rules. A data matrix and further information are provided in the chapter on toxicokinetic properties. The pigment is considered to be non irritating to skin and eyes.

CAS No. 147-14-8:

There are valid in vivo data available for the assessment of the skin and eye irritation potential of Copper phthalocyanine.

Skin

- A Draize test was performed with four White Vienna rabbits, comparable to OECD guideline 404 (BASF AG 1971). A 20-hour occlusive exposure to ca. 1 ml of the test substance (moistured with water and mixed to a paste) produced no effects (overall scores of 0 for all readings 24, 48 and 72 h).

- In a second report, rabbits were exposed to 0.5 g of the powdered test material, mixed to a paste with polyethylene glycol before application, for 24 h under occlusive conditions (Huntingdon Research Centre 1973, Val. 4). According to the author, no signs of irritation were seen during the 72 hours observation period at the intact skin of any animal.

Both results should be considered as overpredictive due to the harsh test conditions if compared to actual guideline recommendations (4 h under semiocclusive conditions).

Eye

A Draize test was performed with twoWhite rabbits, comparable to OECD guideline 405 (BASF AG 1971). 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.

No irritating effects were also observed in a second study, comparable to OECD guideline 405 (Huntingdon Research Centre 1973, Val. 4). Eyes were left unwashed after application and were observed for 7 days. In 5/6 animals no findings were seen at any time point. The scores for Conjunctivae redness and chemosis were combined and expressed as one single value. One animal showed severe conjunctivae effects 24 hours after application of the test material. After 48 hours, the conjunctivae score was moderate. After 72 hours, no more findings were seen in this animal until the end of the observation period (7 days).

In a further test with missing validity, rabbits were exposed to 80 mg of the test material which was instilled into the conjunctival sac of the left eye, the substance was not washed out (Ciba-Geigy Pharmaceuticals 1988, Val. 3). Severe effects were observed on the eyes of the animals. However, the tested material consisted of a total of 7 substances, one of these substances (11 % of the total tested material) was Ethomeen S/12 (CAS No. 73246-96-5), which is known to be able to cause severe skin and eye damage. Therefore, the study is unsuitable for assessment of CAS No. 147-14-8.

CAS No. 1328-53-6:

There are valid in vivo data available for the assessment of the skin and eye irritation potential of Polychloro copper phthalocyanine.

Skin

- A Draize test was performed with six White Vienna rabbits, comparable to OECD guideline 404 (IFREB 1980). A 24-hour occlusive exposure to ca. 0.5 g of the test substance in 0.65 ml of neutralized sterilized olive oil per produced the following effects: Treatment with the test substance resulted in only one out of 6 rabbits in very slight edema after 24 h. The evaluation of erythema after 24 hours was impossible in 2 rabbits due to treatment related colouring of the skin. Very slight to well defined erythema were noticed in 4 rabbits where iritation was reversible after 7 days. Slight desquamation was seen on intact skin in 2/6 animals after 7 days.

- In a second report also comparable to OECD guideline 404, rabbits were exposed to a paste containing the moistened test substance (50 %) for 24 h under occlusive conditions (BASF AG 1971). No formation of edema or erythema was observed at any time point. Substance residues were seen on the treated sites until day 7.

Both results should be considered as overpredictive due to the harsh test conditions if compared to actual guideline recommendations (4 h under semiocclusive conditions).

- No irritant effects were also reported in a study with limited validity in guinea pigs (Putilina 1976, Val. 4). However, no study details were available.

Eye

No irritating effects were observed in a Draize test, comparable to OECD guideline 405 (IFREB 1980). Eyes were left unwashed after application of ca. 100 mg of the undiluted, solid test substance and were observed for 7 days. The following effects observed were observed, but were completely reversible within 72 hours: Test animals showed slight conjunctiva chemosis and redness, which were completely reversible in 5/6 animals within 48 hours; iris congestion was also observed in 3/6 animals and was also completely reversible within 48 hours in 2 of the animals concerned; the cornea was slightly affected in 1/6 animals at 24 h only.

A second Draize test was performed with two White Vienna rabbits, comparable to OECD guideline 405 (BASF AG 1971). Eyes were left unwashed after application of ca. 50 mg of the undiluted, solid test substance into the left eye as well as of ca. 50 mg of talcum (control substance) into the right eye of each animal. Observation period was 8 days. The mean score for conjunctivae redness was 1.0 in the treated eye, but was fully reversible within 8 days. In the control eyes, the mean conjunctivae redness score was also 1.0, and was also fully reversible within 8 days. Scores for cornea, iris and chemosis were 0 at any reading time point in the treated eyes.

- No irritant effects were also reported in a study with limited validity in guinea pigs (Putilina 1976, Val. 4). However, no study details were available.

 

CAS No. 574-93-6:

There are valid in vivo data available for the assessment of the skin and eye irritation potential of Heliogen Blue MFA.

Skin

- A Draize test was performed with three New Zealand White rabbits, comparable to OECD guideline 404 (BASF AG 1979). A 24-hour occlusive exposure to ca. 0.5 ml of the undiluted test material produced the following effects: The evaluation of erythema was impossible in all rabbits due to treatment related colouring of the skin. No to moderate edema was seen in 3 animals, the mean score for edema was 0.83. In one animal the effect was not fully reversible within 8 days (score was 1).

- In a second report, also comparable to OECD guideline 404, rabbits were exposed to ca. 0.8 ml of a paste containing the moistened, pure test substance (ca. 0.5 g) for 24 h under occlusive conditions (BASF AG 1979). The evaluation of erythema was impossible in all rabbits due to treatment related colouring of the skin. No edema formation was seen at any time point.

Both results should be considered as overpredictive due to the harsh test conditions if compared to actual guideline recommendations (4 h under semiocclusive conditions).

Eye

- No irritating effects were observed in a Draize test, comparable to OECD guideline 405 (BASF 1979). Eyes were left unwashed after application of ca. 100 mg of the undiluted, solid test substance and were observed for 8 days. No effects were observed in all 3 animals at any time point.

- Corrosive effects were reported in another study. However, an unsuitable test system was used, as the tested material consisted of 85 % of CAS No. 574-93-6 and 15 % of CAS No. 75247-18-6, the latter is known to be able to cause serious eye damage (BASF 1979, Val. 3).

CAS No. 27614 -71 -7:

There are valid in vivo data available for the assessment of the skin and eye irritation potential of Hostaperm Blau BT-729-D.

Skin

- A test was performed with three New Zealand White rabbits, acc. to OECD guideline 404 (Aventis Pharma 2001). A 4-hour semi-occlusive exposure to 0.5 g test material, pasted with 0.4 ml sesame oil produced no signs of irritation on the clipped skin of any rabbit during the whole study period.

Eye

- No irritating effects were observed in a eye irritation test, acc. to OECD guideline 405 (Aventis Pharma 2001). Eyes were washed 24 h after application of ca. 100 mg of the undiluted, solid test substance and were observed for 72 hours after administration of the test material. One hour after administration the conjunctiva of one animal was very slightly swollen. Furthermore, all animals showed definitely injected blood vessels at one hour up to 48 h after administration. In addition to these observations, serous eye discharge discoloured by compound was noted. 72 h after administration, all signs of irritation had disappeared.

Justification for selection of skin irritation / corrosion endpoint:
Most modern study

Justification for selection of eye irritation endpoint:
Most modern study

Justification for classification or non-classification

None or slight effects effects which were all fully reversible at most within 8 days were seen in the available reliable tests which mostly followed harsh test conditions (>= 20 h under occlusive conditions). 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 skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.