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EC number: 700-870-8 | CAS number: -
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:
- 2 013
- 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
- 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
- Reference substance name:
- Copper phtalocyanine mono- and disulphonated
- IUPAC Name:
- Copper phtalocyanine mono- and disulphonated
- 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:
Constituent 1
Constituent 2
Constituent 3
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).
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