Registration Dossier
Registration Dossier
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EC number: 442-640-7 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-12-13 to 2002-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 96/54/EG, B.1tris (Akute-toxische-Klassen-Methode); OECD 423
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 442-640-7
- EC Name:
- -
- Cas Number:
- 479541-17-8
- Molecular formula:
- Hill formula: C32H26CuFN9Na4O19S5
- IUPAC Name:
- Tetrasodium 2-(4-fluoro-6-(2-(2-sulfonatoethansulfonyl)ethyl amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(2-(2-hydroxy-5- sulfonatophenylazo)-4,5-dimethoxyphenylazo)-7-sulfonatonaphthalene-1-sulfonatocuprate(II)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Oliv F00-0149
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: Males=204g; Females=199g
- Housing: in transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days
- Fasting period before study: fasted before receiving dose
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: received the compound as a 20 % suspension in deionized water
- Amount of vehicle (if gavage): 10 mL/kg body weight - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: symptoms observed twice daily, once on weekends and public holidays; animals weighed weekly
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg body weight; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg body weight; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: No clinical symptons were observed after the application of the testing substance.
- Gross pathology:
- No gross pathology changes
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median LD50 (oral) of Reactive Olive F00-0149 for male and female rats is >2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study, groups of 3 animals/sex of HSD Sprague Dawley Rats aged 6-10 weeks, were given a single oral dose of Reactive Olive F00-0149 in deionized water at a doses of 2000 mg/kg body weight and observed for 14 days.
Oral LD50
Male = >2000 mg/kg body weight
Female = >2000 mg/body weight
Combined = >2000 mg/kg body weight
Reactive Olive F00-0149 is of Low toxicity based on the LD50 in male and female rats
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