Trisodium [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cuprate(3-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Methodology comparable to internationally accepted guidelines

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cuprate(3-)

EC Number:

215-538-3

EC Name:

Trisodium [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cuprate(3-)

Cas Number:

1330-39-8

Molecular formula:

C32H13CuN8O9S3.3Na

IUPAC Name:

trisodium [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cuprate(3-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: FAT 20063/D TE
Lot: BS-BOP 01-15
Appearance: Dark blue powder

Specific details on test material used for the study:

None

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy random bred rats of the Tif: RAIf (SPF) strain (7-8 weeks old) raised on the premises were used for this experiment. They were kept at a room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3 ), individually marked with picric acid.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

carboxymethyl-ce11ulose 2 % (w/v) in distilled water

Details on oral exposure:

FAT-20'063/B was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Volume (ml/kg body-weight): 20

Animals fasted overnight were treated by single oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.

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 and weighing: Observations of mortality and clinical signs at 1, 2, 3, 5 and 24 hrs, and daily thereafter for 14 days; Weighing on days 1, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

Sedation, dyspnoea, ruffled furs, diarrhoea, and curved body position were observed. The animals recovered within 8 days.

Body weight:

No effect on body weight gains was seen.

Gross pathology:

No substance related gross organ changes were seen.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was determined to have a LD50 of >5000 mg/kg bw.

Executive summary:

The acute toxicity of the test substance was evaluated in a limit test conducted according to the methodology equivalent to OECD Guideline 401. 5 male and 5 female rats received the test item at the single dose of 5000 mg/kg bw by oral intubation. Observations of mortality and clinical signs were carried out after 1, 2, 3, 5 and 24 hrs of dosing, and daily thereafter for 14 days; while weighing was done on days 1, 7 and 14. The surviving rats were subjected to necropsy at the end of observation period. No mortality was observed through the duration of the study. Clinical signs like sedation, dyspnoea, ruffled furs, diarrhoea, and curved body position were observed. The animals recovered within 8 days. No effect on body weight gains was seen. No substance related gross organ changes were seen during the gross pathological examination. Hence, based on the above findings, the test substance was determined to have a LD50 of >5000 mg/kg bw.