Polychloro copper phthalocyanine

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1981

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Polychloro copper phthalocyanine

EC Number:

215-524-7

EC Name:

Polychloro copper phthalocyanine

Cas Number:

1328-53-6

Molecular formula:

C32HxClyCuN8

IUPAC Name:

[1,2,3,4,8,9,10,11,15,16,17,18,22,23,25-pentadecachloro-5,26-dihydro-29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper

Test material form:

solid

Specific details on test material used for the study:

- Analytical purity: ca. 98 %

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met