Copper phtalocyanine monosulfonated and disulfonated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19. 8. - 3. 9. 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was carried out according to internationaly valid method and in accordance with GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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

Constituent 1

Reference substance name:

Copper phtalocyanine monosulfonated and disulfonated

EC Number:

700-870-8

Molecular formula:

C32H15N8Cu(HSO3)n where n=1.3-1.6

IUPAC Name:

Copper phtalocyanine monosulfonated and disulfonated

Constituent 2

Reference substance name:

Copper phtalocyanine mono- and disulphonated

IUPAC Name:

Copper phtalocyanine mono- and disulphonated

Constituent 3

Reference substance name:

Hysperse 12

IUPAC Name:

Hysperse 12

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Copper phtalocyanine mono- and disulphonated
- Molecular formula (if other than submission substance): C32H15N8Cu(SO3H)1.4x2.5 H20
- Molecular weight (if other than submission substance): 733.3
- Substance type: multicomponent
- Physical state: powder
- Analytical purity: 99.5
- Impurities (identity and concentrations): 0.5 % water soluble salt
- Lot/batch No.: 01
- Stability under test conditions: stabil
- Storage condition of test material: In original container in dry place at the room temperature.
- Other:

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s. r. o. Koleč u Kladna, Czech Republic
- Age at study initiation: 8 - 12 weeks at the time application
- Weight at study initiation:
- Fasting period before study:
- Housing: animal room with monitoring conditions - 3 animals in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): ST1 BERGMAN- standard pellet diet ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: min 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2013-08-19 To: 2013-09-03

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
-Aqua pro injectione
Batch No. 0101050612
Expiration: 06/2014
Manufacturer: ARDEAPHARMA a. s., Ševětín, Czech republic

MAXIMUM DOSE VOLUME APPLIED: 2 ml

DOSAGE PREPARATION (if unusual):
Immediately before application the test substance was weighed, mixed in water and resulting solution was administred to the stomach by tube.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test 2000 mg/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

Step 1: 3 females
Step 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
weighing: before administration, 8th day, 15 th day (before euthanasia)
observation: first day twice (30 min and 3 hr after administration)
second day twice (in the morning and in the afternoon)
daily thereafter for 14 days

- Necropsy of survivors performed: yes/no
All test animals survived to the end of study were sacrificed on the 15 th day by injection of veterinary preparation T61 (1 ml iv.) and gross necropsy was
carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

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

Gross pathology:

Without pathological changes in both steps.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

According the study results the value of LD50 of the test substance, Hysperse 12, for female rats is higher than 2000 mg/kg of body weight. Substance is not classified as acute oral toxic according CLP criteria (regulation (EC) No. 1272/2008).