29H,31H-phthalocyanine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

non-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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: particulate/powder

Specific details on test material used for the study:

- Analytical purity: 100 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Farm VELAZ
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 236-278 g
- Housing: individually in plastic breeding cage Velaz T4
- Diet: DOS 2b - standard pelleted diet, ad libitum
- Water: drinking tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The amount of the test substance for each animal was weighed (acc. to its body weight) and moistened with water for injection immediately before application.
Approx. 24 h before application of the test substance, the fur on the back of the animals was shaved at area about 6 cm x 6 cm.
Aliquot part of the test material was applied on the depilated area of skin. The application site was covered by mull, plastic foil and held in contact by plaster (strapping). After 24 h the occlusive dressing and the remains of the test substance were removed.

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

Body weight:
Animals were weighed before application, at 8th day and before euthanasia of animals. Average body weight in a group was calculated from individual body weights.

Clinical examination:
After application of the test material the animals were observed individually. Observations included changes of health conditions. Observations were performed daily during the 14 days observation period.

Pathological examination:
All test animal survivors to the end of the study were sacrificed on the 15th day and gross necropsy was carried out. Normally the nutritious state, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All animals survived the 14 day observation period and the day of sacrifice.

Clinical signs:

other: No clinical signs of toxicity were observed during the study period.

Gross pathology:

No individual records of macroscopic changes were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met