Polychloro copper phthalocyanine

Endpoint summary

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Analytical purity: ca. 98 %

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Average weight at study initiation: males: 180 g; females 160 g
- Fasting period before study: 15 to 20 hours prior to application
- Diet: Herilan MRH-Haltung (H. Eggersmann KG), ad libitum
- Water: ad libitum

Route of administration:

oral: gavage

Vehicle:

other: suspension containing 0.5 % CMC and 1-2 drops Cremophor EL

Details on oral exposure:

- Concentration of the test material in vehicle: 50 %
- Amount of test material applied per gavage: 10 ml/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed and examined for clinical signs of toxicity during the first hour following application at 15 min, 30 min and 60 min, after 2, 4 and 5 hours and further on day 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14 after dosing.
- The body weights of the individual animals were gathered prior to application of the test material and on day 3, 7 and 13 after dosing.
- Necropsy of survivors performed: Deceased animals and those sacrificed at the end of the observation period (on day 14 after dosing) were necropsied.

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 5 000 mg/kg bw

Mortality:

All animals survived, no mortality was observed.

Clinical signs:

other: Dyspnea, apathy, green feces as well as a poor general state were observed.

Gross pathology:

Autopsy revealed no relevant findings.

Table 1: Mean body weight (g) of rats after oral application of the test substance

	Males	Females
Dose level [mg/kg bw]	5000	5000
Day 2-4	213	187
Day 7	237	198
Day 13	266	173

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Oral

There are valid data available for the assessment of the acute oral toxicity of polychloro copper phthalocyanine. Five male and five female Sprague-Dawley rats were treated with doses of 200, 1600, 3200 and 6400 mg/kg bw of polychloro copper phthalocyanine under standardized conditions; the test method is comparable to OECD guideline 401 (BASF AG, 1971). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 6400 mg/kg bw for male and female rats. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Green feces were observed in all animals treated 24 hours after application of the test material. Dyspnea was observed in animals of the 1600 mg/kg bw group immediately after treatment, but was reversible.

In a supporting limit test,comparable to OECD guideline 401, five Sprague-Dawley rats per sex were administered to a single dose of 5000 mg/kg bw polychloro copper phthalocyanine (BASF AG 1980). The animals were observed for 14 d, necropsy was performed even with the survivors. Here, the LD50 was > 5000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Dyspnea, apathy, green feces as well as a poor general state were observed. A slight decrease of the average body weight in the female group was seen on day 13.

Other studies in rat with partially limited reliability provided a LD50 range of > 2000 to > 10000 mg/kg bw polychloro copper phthalocyanine in rats, in all three cases no mortalities occured (JETOC 2001, Val. 2; JETOC 1997, Val. 2; Putilina 1976, Val. 4).

The LD 50 value for another common test species (mouse) was > 10000 mg/kg bw polychloro copper phthalocyanine (Gosselin 1976, Val. 4).

Inhalation

No valid data are available for the assessment of the acute inhalation toxicity of polychloro copper phthalocyanine. A standardized inhalation hazard test was conducted to assessthe acute inhalation toxicityof polychloro copper phthalocyanine. However, the system used was unsuitable in this case (Val. 4), as the IHT is insufficient for non-volatile substances, such as the solid substance polychloro copper phthalocyanine. 0/6 rats died after 7 h exposure at room temperature. No clinical signs of toxicity were seen and autopsy revealed no abnormal findings. A considerable formation of dust was reported (BASF AG 1980).

 

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. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the fifteenth time in Regulation (EC) No. 2020/1182.