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EC number: 457-630-8 | CAS number: 2138836-26-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicity to microorganisms
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- Toxicological Summary
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- Acute Toxicity
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 27, 2004 to October 14, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 457-630-8
- EC Name:
- -
- Cas Number:
- 2138836-26-5
- Molecular formula:
- Hill formula: C29H23FN8Na4O16S5
- IUPAC Name:
- tetrasodium 3-amino-4-[(1E)-2-[4-({4-fluoro-6-[phenyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- 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
- Body weight range at treatment: 178-191 g
- Housing: In transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet: Ssnif R/M-H (V 1534), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d
- Animal identification: Fur marking with KMnO4 and cage numbering
- Randomization procedure: Computer generated algorithm (archived with raw data) Randomization scheme 2004.0213
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (short lasting deviations are permissible, e.g., during cleaning processes)
- Humidity: 50±20% (short lasting deviations are permissible, e.g., during cleaning processes)
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: September 27, 2004 to October 14, 2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% solution in deionized water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Test substance was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit test (according to toxicity data of related compounds). - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- six (female only)
- Control animals:
- no
- Details on study design:
- TEST PROCEDURE
The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 d. Symptoms were recorded twice every day (i.e., in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: Reddish discolored urine and feces were observed in the animals starting 2-4 h after the administration of test substance. From Day 3 until the end of the study no symptoms were observed.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the oral LD50 was found to be >2000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance in female Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP.
Group of six female fasted rats received a single oral (gavage) dose of 2000 mg/kg bw. A 20% solution of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw.
No mortality occurred, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy. Reddish discolored urine and feces were observed after the administration of test substance for up to 2 d. There were no further symptoms from Day 2 until end of the study.
Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.
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