Registration Dossier
Registration Dossier
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EC number: 249-300-5 | CAS number: 28901-96-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (December 17, 2001)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bioassay, Labor für biologische Analytik GmbH, Heidelberg)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)
- EC Number:
- 249-300-5
- EC Name:
- Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)
- Cas Number:
- 28901-96-4
- Molecular formula:
- C32H15CuN8O3S.H
- IUPAC Name:
- Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)
- Details on test material:
- - Physical state: Solid, blue
Purity: > 99%
- Lot/batch No.: 130001 /RA gemahlen
- Expiry date: 17 Feb 2034
- Stability: The stability of the test substance under storage conditions throughout the study period was guaranteed until Jan 2022 as indicated by the sponsor.
- Storage condition of test material: room temperature
- Homogeneity: The homogeneity of the test substance was ensured by mixing before preparation of the test substance solutions.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 10 – 11 weeks
- Weight at study initiation: mean weight test group 1: ; mean weight test group 2:
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.24 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: structure activity considerations - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Additionally, at day of death in animals that died or were sacrificed moribund starting with study day 1. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes - Statistics:
- Calculations were performed using Microsoft Excel 2003 and checked with a calculator.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred.
- Mortality:
- none
- Clinical signs:
- other: During the first five hours after dosing, piloerection was observed in two animals of each test group.
- Gross pathology:
- There were no adverse findings observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
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