[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

Corrosion study + Weight of Evidence

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 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))

Deviations:

yes

Remarks:

The TER value at the reading time 24 hours for the positive control was slightly higher than the range 0.5 - 1.0 defined in OECD test guideline (1.2 versus 1.0 kW). This deviation was without any impact in the results of the study.

GLP compliance:

yes (incl. QA statement)

Test system:

isolated skin discs

Source species:

rat

Source strain:

Sprague-Dawley

Details on animal used as source of test system:

Young rats (Sprague Dawley strain) were required for the preparation of skin discs. Two animals were supplied by the Elevage Janvier Labs (F-53941 Le Genest Saint Isle).
The dorsal and flank hair were carefully removed with small animal clippers. The animals were then washed by careful wiping, whilst submerging the area in 0.5 mL of antibiotic solution (Batch No.: 067M4815V) at D-5, D-2 and D-1.

Vehicle:

unchanged (no vehicle)

Remarks:

150 µl of distilled water was added on top of the solid

Details on test system:

The skin discs were prepared from three SPF female Sprague Dawley rats, which were 4 weeks old
the day of the test and were identified Rf2220 and Rf2221.
The dorsal skin was placed over a PTFE (polytetrafluoroethylene) tube with a rubber ‘O’ ring. The tube was placed inside a receptor chamber containing a magnesium sulfate solution (154 mM).
Each skin disc had been validated with the measures of the transcutaneous electrical resistance value (values higher than 10 kW).

Control samples:

yes, concurrent vehicle

yes, concurrent positive control

Amount/concentration applied:

0.03g of the test item. Just after the treatment, 150 µL of distilled water was added on top of the solid.

Duration of treatment / exposure:

24 hours

Number of replicates:

3 epidermal surfaces of skin disc.

Species:

rat

Strain:

Sprague-Dawley

Type of coverage:

not specified

Preparation of test site:

clipped

Irritation / corrosion parameter:

transcutaneous electrical resistance (in kΩ)

Remarks:

After 24 hours

Value:

22.3

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

transcutaneous electrical resistance (in kΩ)

Remarks:

At T0

Value:

25.61

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

For further details, please refer to the illustration hereafter

Interpretation of results:

other: Non-corrosive

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item Cobalt Phtalocyanine (PcCo) does not have to be classified as corrosive, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or the danger labels are required. In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified in category 1 “Corrosive”.

Under test conditions, the test item is not considered as corrosive.

Please refer to endpoint summary for justification on classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

chicken

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: slaughterhouse
- Age at study initiation: 7 weeks old
- Weight at study initiation: 1.5 - 2.5 kg

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg w/w

Duration of treatment / exposure:

10 seconds then eyes were rinsed twice with 10 mL of physiological saline at ambient temperature. As test item remained on the corea despite rinsing, an additional rinse was performed with 3x10 mL of physiological saline.

Duration of post- treatment incubation (in vitro):

30, 75, 120, 180 and 240 min

Number of animals or in vitro replicates:

3 eyes/group

Details on study design:

NEGATIVE CONTROL USED : physiological saline

POSITIVE CONTROL USED : sodium hydroxide


METHODS FOR MEASURED ENDPOINTS: according to OECD guideline.


SCORING SYSTEM:
- Mean corneal swelling (%)
- Mean maximum opacity score
- Mean fluorescein retention score at 30 minutes post-treatment

DECISION CRITERIA: according to OECD guideline.

Irritation parameter:

cornea opacity score

Run / experiment:

Max value

Value:

1.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

fluorescein retention score

Run / experiment:

Mean value

Value:

1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

percent corneal swelling

Run / experiment:

Max mean value (%)

Value:

2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

study cannot be used for classification

Conclusions:

According to OECD 438 study, GLP compliant and under experimental test condtions, no prediction can be made. No classification can be set according to CLP regulation.

Refer to endpoint summary for final conclusion.

Reference 2

Endpoint:

eye irritation: in vitro / ex 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

human

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Temperature : 37°C
CO2 : 5%
Humidity : 95%

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

yes, concurrent positive control

Amount / concentration applied:

50 mg

Duration of treatment / exposure:

6 hours

Duration of post- treatment incubation (in vitro):

25 minutes post-exposure immersion period at room temperature in 5 mL of fresh medium to remove any test item absorbed into the tissue, then, the RhCE constructs were incubated for an 18 hours and 01 minute post-exposure incubation at standard culture conditions in 1 mL of fresh medium at 37°C, 5% CO2.

Number of animals or in vitro replicates:

2 replicate per conditions

Details on study design:

The test item Cobalt Phthalocyanine was applied at the dose of 50 mg to 2 living DPBS pre-treated RhCE (EpiOcularTM tissue model) during 6 hours at 37°C, 5% CO2, 95% humidity (standard culture conditions). The exposure period was followed by extensive rinsing with DPBS at room temperature, a 25 minutes post-exposure immersion period at room temperature and an 18 hours and 01 minute post-exposure incubation at standard culture conditions. The tissue viability was measured by performing an MTT assay. Additionally, 2 killed RhCE (EpiOcularTM tissue model) were treated in the same manner in order to generate non-specific MTT reduction. Moreover, 2 living and 2 killed RhCE (EpiOcularTM tissue model) were treated in the same manner but they were incubated in culture medium instead of MTT solution in order to generate non-specific living and killed colour controls.

Irritation parameter:

other: % of viability

Value:

74.42

Negative controls validity:

valid

Remarks:

% viability: 100.00%

Positive controls validity:

valid

Remarks:

% viability : 32.96%

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item Cobalt Phthalocyanine does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category. No hazard statement is required.

To conclude, based on OECD 492 (2015), GLP study, Cobalt Phthalocyanine is not considered as eye irritant or serious eye damage according to CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Skin irritation:

Based on OECD 430 GLP study, Cobalt Phthalocyanine did not show evidence of skin corrosive effect. However, these results have to be considered as part of an integrated approach.

It can be noted that usually, this result should be considered together with in vitro assays to assess skin-irritating properties of the test material. Nevertheless, regarding the chemical structure (metal compound insoluble in water and octanol) of the substance, carrying these kinds of assays is not feasible Therefore, only OECD 430 test has been performed. 

 

Besides, from data on 29H,31H-phthlalocyanine (EC number: 209 -378 -3, CAS number: 574 -93 -6) on ECHA website, only 2 of 82 notifiers reported that this substance require a classification for skin irritating (Cat 2).

For cobalt, a harmonised classification is available, and no skin irritating property have been identified (refer to Annex VI of CLP Regulation).  

To conclude, in a weight of evidence approach and in order to avoid unnecessary testing on animals, considering all the elements listed above, it can be concluded that Cobalt Phthalocyanine does not have skin irritating potential.

Eye irritation

According to Annex VII, column 2, only in vitro studies are foreseen. Therefore, 2 in vitro studies using Cobalt Phthalocyanine as test item have been provided in the IUCLID dossier:

- one GLP study performed according to OECD 438 (2013), Klimisch 1, with the following conclusion:" no prediction can be made".

- one GLP study performed according to OECD 492 (2015), Klimisch 1, with the following conclusion: "Cobalt Phthalocyanine is not considered as eye irritant or serious eye damage according to CLP criteria".

To conclude, Cobalt Phthalocyanine does not require classification according to CLP criteria.