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

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:

other: see 'Remark'

Remarks:

Meets generally accepted scientific standards, well documented study with the following restriction: In some cases in the highest dose group the application volume per animal slightly exceeded the volume of 2 ml/100 g bw, which is recommended in OECD guideline 401 as maximum application volume for aqueous solutions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test:
In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period. The LD50 value was estimated on the basis of the observed mortalities.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test type:

standard acute method

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:

copper polyphthalocyanine

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Analytical purity: 100 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Gassner, Ottobrunn; SPF breeding
- Average weight at study initiation: males: ca. 170 g; females: ca. 145 g
- Diet: Altromin-R (Altrogge, Lage/L., Germany), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Concentration of the test material in vehicle:
- 30 % (6400 and 3200 mg/kg bw)
- 16 % (1600 mg/kg bw),
- 2 % (200 mg/kg bw)

Amount of test material applied per gavage:
- 21.3 ml/kg bw for 6400 mg/kg bw;
- 10.6 ml/kg bw for 3200 mg/kg bw;
- 10.0 ml/kg bw for 1600 mg/kg bw;
- 10.0 ml/kg bw for 200 mg/kg bw

Doses:

200, 1600, 3200, 6400 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

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, after 4 hours and further on day 1, 4, 5, 6, 7, 8, 11, 12, and 13 after dosing.
- The body weights of the individual animals were gathered prior to application of the test material.
- Necropsy of survivors performed: yes. 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:

LD50

Effect level:

> 6 400 mg/kg bw

Mortality:

No mortality was observed at any dose group.

Clinical signs:

other: - 6400 - 3200 mg/kg bw: Ca. 4 hours after application the animals were found in a crouched down position with intermittent breath. On the following morning slight apathy,a crouched down position and intermittent breath were observed. The stool of the anim

Gross pathology:

Autopsy revealed no relevant findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the BASF test (similar to OECD guideline 401) for acute toxicity after oral application, the LD50 for the test material is > 6400 mg/kg body weight for male and female rats.