[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]iron

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

not specified

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

EC Number:

205-685-1

EC Name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

Cas Number:

147-14-8

Molecular formula:

C32H16CuN8

IUPAC Name:

[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper

Test material form:

solid: crystalline

Specific details on test material used for the study:

not specified

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

Intragastric administration of a maximum achievable dose of CPC to female rats.

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

DMSO

Details on exposure:

In the course of 30 days it was administered intragastrically

Doses:

maximum achievable dose of CPC (20% suspension in 2% starch (6g/kg) and 50% suspension in dimethyl sulfoxide (15g/kg))

No. of animals per sex per dose:

not specified

Control animals:

yes

Details on study design:

Body weight, blood serum alkaline phosphatase, neuromuscular stimulation threshold (rheobase), mass coefficients of internal organs were not different form the control test. However, during the subacute experiment the amount of metaprotein (ceruloplasmin) content in blood serum was increasing after 10 and 20 days from the beginning of the experiment. After 30 days from the end of experiment ceruloplasmin content in animals blood was within the norm.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

other: mortality

Effect level:

2.39 other: mg/ml

Based on:

test mat.

Mortality:

0

Any other information on results incl. tables

Total and electrovalent copper was determined using atomic absorption spectrometry. The ionised copper content in blood serum of the experimental animals was increasing after 6hs in comparison with benchmark test results (in the experiment, 1.8 ± 0.08 μg/ml, in the control 1.6 ± 0.02 μg/mI). After 24h after experiment copper content was still higher than benchmark results. Atomic absorption spectrometry data demonstrate that difference in copper content between benchmark tests and experimental tests was 6.2 μg/ml or 0.04 mg per animal which is only 0.01%w of the total copper amount in CPC given to the animals (37.47 mg per an animal).

Applicant's summary and conclusion

Conclusions:

1. After carefully analysis of obtained data we can conclude that CPC does not penetrate the blood and does not metabolise in the organism.
2. Toxicity of copper phthalocyanine pigment is due to contamination with soluble copper salts.
3. Purified pigment can be recommended for the mass production with its maximum allowed concentration in the air of the working area 5mg/m3 due to ability of CPC adsorb to the skin and dye it, III hazard class.
4. Being biologically inert insoluble copper phthalocyanine pigment can be considered as a low-hazard substance

Executive summary:

1.       After carefully analysis of obtained data we can conclude that CPC does not penetrate the blood and does not metabolise in the organism.

2.       Toxicity of copper phthalocyanine pigment is due to contamination with soluble copper salts.

3.       Purified pigment can be recommended for the mass production with its maximum allowed concentration in the air of the working area 5mg/m3 due to ability of CPC adsorb to the skin and dye it, III hazard class.

4.       Being biologically inert insoluble copper phthalocyanine pigment can be considered as a low-hazard substance