Low chlorinated copper, [29H,31Hphthalocyaninato(2-)-N29,N30,N31,N32]-, wherein the number of chlorines is more than or equal to 0 and less than or equal to 7

Endpoint summary

Description of key information

The substance was found to be non irritant to rabbit skin and eyes as tested in GLP and OECD testing guideline compliant studies (OECD 404 and 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Analytical purity: >85%
- Lot/batch No.: M200058
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff (R) K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +- 3 °C
- Humidity: 50 +- 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: sesame oil

Controls:

other: untreated shaved skin served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g test material, pasted with 0.4 ml sesame oil

Duration of treatment / exposure:

The exposure period was 4 hours.

Observation period:

72 hours after removal of the patches.

Number of animals:

3 females

Details on study design:

About 24 h before the start of the study the hair in the dorsal region of the body of the animals was removed with an electric clipper over an area of ca. 25 cm2. Only animals with intact skin were used.
Each animal was treated with the test material, the substance was evenly distributed over the whole surface of a 2.5 cm x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf AG). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 h, after the exposure all remnants of the test material were carefully removed from the skin with warm tap water.
Examinations of the skin took place 30 - 60 min as well as 24, 48 and 72 h after removal of the patches.
Erythema, eschar formation and edema were evaluated numerically, acc. to the score of Draize. All other changes of the skin were recorded.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

No signs of irritations were observed during the study.

Interpretation of results:

GHS criteria not met

Conclusions:

No signs of irritation were seen on the skin of the rabbits during the whole study period under the experimental conditions chosen here. Therefore, the test material has not to be classified according to GHS- or EU criteria.

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Analytical purity: >85%
- Lot/batch No.: M200058
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Weight at study initiation: 2.6 - 2.9 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff (R) K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +- 3 °C
- Humidity: 50 +- 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h after administration of the test material

Number of animals or in vitro replicates:

3 females

Details on study design:

About 24 h before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
100 mg of the test material was administered once to the conjunctival sac of the left eyeof three animals. In each case the untreated eye served as control.
24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
The eyes were examined 1, 24, 48 and 72 h after administration of the test material. At 24 and 72 h, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically acc. to Draize. All other changes or toxic effects were recorded when apparent.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.56

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

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, serious eye discharge discoloured by compound was noted. 72 h after administration all signs of irritation had disappeared.

Interpretation of results:

GHS criteria not met

Executive summary:

Slight signs of irritation (a mean score of 0.56 for 3 animals at 24 -48 -72 h for conjunctivae redness) were seen in the eyes of the rabbits which were fully reversible within 72 h under the experimental conditions chosen here. Therefore, the test material has not to be classified according to GHS- or EU criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a GLP compliant study according to OECD 404, three female rabbits were treated with 0.5 g test material (pasted with 0.4 mL sesame oil) over a 2.5 cm x 2.5 cm dorsal area, that was previously shaved. the application site was covered with a semi-occlusive bandage. The exposure period was 4 h, after the exposure all remnants of the test material were carefully removed from the skin with warm tap water.  Examinations of the skin took place 30 - 60 min as well as 24, 48 and 72 h after removal of the patches. Erythema, eschar formation and edema were evaluated numerically, acc. to the score of Draize. All other changes of the skin were recorded. No signs of irritation were seen on the skin of the rabbits during the whole study period.

 

Eye irritation

In a GLP compliant study according to OECD 405, 100 mg of the test material was administred once to the conjunctival sac of the left eye of three rabbits. In each case, the untreated eye served as control. 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.  The eyes were examined 1, 24, 48 and 72 h after administration of the test material. At 24 and 72 h, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically acc. to Draize. All other changes or toxic effects were recorded when apparent. 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, serious eye discharge discoloured by compound was noted. 72 h after administration all signs of irritation had disappeared. Slight signs of irritation (the mean 24 -48 -72 h scores for the individual animals ranging between 0.33 - 0.67 for conjunctivae redness) were seen in the eyes of the rabbits which were fully reversible within 72 h under the experimental conditions chosen here.

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. A GLP-compliant OECD 404 study is available for skin irritation. A GLP-compliant OECD 405 study is available for eye irritation. In both studies, the scores for the test item treated tissues were below the thresholds for classification as an irritant as specified in Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217. As a result the substance is not considered to be classified for skin or eye irritation.