[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

EC Number:

222-012-7

EC Name:

[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

Cas Number:

3317-67-7

Molecular formula:

C32H16N8Co

IUPAC Name:

[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes.

- Age at study initiation: 8-week old.

- Weight at study initiation: between 201 to 210 grams.

- Fasting period before study: Food was removed on day 1 and then redistributed 4 hours after the test item administration.

- Housing: Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and relative humidity during the main test were controlled to remain within target ranges of and , respectively.

- Diet and water: Drinking water (tap-water from public distribution system) and foodstuff (ENVIGO - 2016) were supplied ad libitum. Food was removed on day 1 and then redistributed 4 hours after the test item administration.
Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas – Eurofins (FRANCE). The results of analysis were kept in the Quality Assurance department and then were retained in the Phycher archives as meta-data.

- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C.

- Humidity (%): 30% to 70%.

- Air changes (per hr): The rate of air exchange was at least ten changes per hour.

- Photoperiod (hrs dark / hrs light): twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg bw.

Doses:

limit test: 2000 mg/kg bw

No. of animals per sex per dose:

6 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 30 min, 1h, 3h, 4h, 24h, 48h after administration of the test item and continued
daily during 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Remarks:

3 females by step

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/ kg body weight by oral route in the rat.

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed during the study.

Body weight:

The body weight evolution of the animals remained normal during the study.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment related
changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Cobalt Phthalocyanine is higher than 2000 mg/ kg body weight by oral route in the rat.
In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/ kg body weight by oral route in the rat.
The test item Cobalt Phthalocyanine does not have to be classified in accordance with the Regulation EC No. 1272/2008.