Reaction product of Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium, sulphuric acid and caustic soda

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:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

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:

Groups of 5 male and 5 female rats, fasted overnight, were treated by single oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period of 14 days.

GLP compliance:

no

Remarks:

Study pre-dates GLP regulations

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

EC Number:

307-259-1

EC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Cas Number:

97592-62-6

Molecular formula:

not available

IUPAC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

Name as used in the study report: FAT 60149/A.

Test animals

Species:

rat

Strain:

other: Tif: RAIF (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST Animals
- Age at study initiation: 7 to 8 weeks old
- Mean body weights per group at study initiation: between 159 and 191 g.
- Fasting periode before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: ad libitum rat food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 or 20 mL/kg

Doses:

3000, 5000, 8000, 9000 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: 1, 2, 4, 6, 24 hours after administration; daily from day 2 to day 14
- Frequency of weighing: immediately prior to dosing and at 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

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:

5 581 mg/kg bw

Based on:

test mat.

95% CL:

4 549 - 6 652

Remarks on result:

other: LD50 for male animals between 5000 and 8000 mg/kg bw and for female animals between 3000 and 5000 mg/kg bw.

Mortality:

- 3000 mg/kg bw: No mortality occurred.
- 5000 mg/kg bw: 0/5 male and 4/5 female animals died at day 1 of the test.
- 8000 mg/kg bw: 3/5 male and 5/5 female animals died at day 1 of the test.
- 9000 mg/kg bw: all animals died between day 1-2 of the test.

Clinical signs:

other: - 3000 mg/kg bw: sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position (all slight). After 9 days no symptoms. - 5000 mg/kg bw: symptoms as described above; generally slight, some moderate sedation. After 9 days no symptoms. - 800

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met