[[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

The study is practically non-toxic in rats after single ingestion and dermal application. An inhalation study performed with poorly characterized dust did not show acute inhalation toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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, prior to OECD guidelines. Design and reporting details adequate.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Higher doses tested; only 7 day observation period.

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight: males 241 g, females 176 g

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Suspension in 0.5% aqueous CMC solution
Test concentration used: 35%

Doses:

4640 and 10000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

None

Clinical signs:

other: Partly feces dark-blue coloured

Gross pathology:

Nothing abnormal detected

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Quality of whole database:

Klimisch 2

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1976

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Principles of method if other than guideline:

Animals are exposed to dust generated by blowing air through a layer of the test material

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight: 191 g

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrically

Duration of exposure:

8 h

Concentrations:

5.95 mg/l

No. of animals per sex per dose:

12

Control animals:

other: air control

Details on study design:

Particle size distribution not determined. The concentration of the test material in the air was calculated from the volume of blown air and the difference in the weight of the test material layer before and after the study.

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 5 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: Particle size distribution unknown

Mortality:

None

Clinical signs:

other: Slight mucosal irritation

Gross pathology:

Nothing abnormal detected

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

> 5 mg/m³ air

Physical form:

inhalation: aerosol

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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, prior to OECD guidelines, design and reporting details adequate

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

higher dose; body weight not reported.

Principles of method if other than guideline:

according to D.N. Noakes and D.M. Sanderson: A Method for Determining the Dermal Toxicity of Pesticides; Brit. J. Ind. Med. 26, 59 (1969)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight: males 148 g, females 131 g

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

A 50% test substance concentration was used.

Duration of exposure:

24 hours

Doses:

2500 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Application area: 50 cm2
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

None

Clinical signs:

other: During and after application as well as after the 14-day observation period, the animals were brisk. Local findings after 24 hours: all animals blue test substance residues, reddening not visible. Local findings after 8 days: light-blue substance residues

Gross pathology:

Nothing abnormal detected

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Quality of whole database:

Klimisch 2

Additional information

The experimental data on acute toxicity were generated prior to the introduction of GLP and OECD testing guidelines. Study reports containing adequate description of the experimental procedure and results and with adequate identification of the test substance are available.

The protocol for acute oral toxicity differs from the OECD testing guideline by the shorter observation period (7 instead of 14 days) and by a five-fold higher dose (10000 instead of 2000 mg/kg bw) (BASF 1976). Considering the lack of toxicity observed under these testing conditions, the study is considered to provide sufficient information despite the shorter oberservation period. Blue discoloration of the feces indicated passage of the blue colorant through the gastrointestinal tract.

The protocol for acute dermal toxicity differs from OECD testing guideline 402 by a higher dose of 2500 mg/kg bw. No systemic toxicity was observed during the 14 -day observation period. As the test item coloured the application site, local effects could not be completely during the first part of the study. Then later no local effects were noted.

An acute inhalation study with poorly characterized dusty material in rats was performed (BASF 1976). The test atmosphere was generated by blowing air through a layer of the test material and the concentration was calculated from the weight difference of the layer of the test material. During the 8h exposure, an average concentration of ca. 5mg/L was applied. No particle size characterization and no online concentrations are available, therefore the study is only indicative. No rat died as a consequence of treatment.

For additional information, an acute inhalation study with phthalocyanine (OECD 403, GLP, BASF 2021) was taken into account. Particle characterization confirmed that the material was a nanomaterial. At the limit dose of 2 mg/L of dust, one of ten rats died during the 4h exposure period. No indication of systemic toxicity was observed at necropsy at the end of the observation period.

In addition, a study with intraperitoneal application of 2000 mg/kg bw is available (BASF 1976). No animal died during the 8 -day observation period.

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 acute toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.