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EC number: 201-369-2 | CAS number: 81-68-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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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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- Toxicological Summary
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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 12 October, 1993 to 3 November, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide
- EC Number:
- 201-369-2
- EC Name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide
- Cas Number:
- 81-68-5
- Molecular formula:
- C22H18N2O5S
- IUPAC Name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature
Test animals
- Species:
- rat
- Strain:
- other: (Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein/Switzerland
- Weight at study initiation: 174 to 237 g
- Fasting period before study: Overnight
- Housing: Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: Ad libitum
- Acclimation period: At least for 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 22±2 °C
- Humidity: 55±10 %
- Air changes: CA 15 air changes/h
- Photoperiod: 12 h dark/12 h light cycle
IN-LIFE DATES: From October 12, 1993 to November 3, 1993
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw (males and females)
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Clinical signs: Daily for 14 d: Body weight: Immediately before administration and on Days 7 and 14.
- Necropsy of survivors performed: Yes, at the end of the observation period. - Statistics:
- The LD50 value with 95 % confidence limits were calculated, where possible.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 860 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortalities occurred in the study.
- Clinical signs:
- other: Piloerection, hunched posture and dyspnoea were seen within 1 h of test substance administration. The animals recovered within 5 to 6 d.
- Gross pathology:
- No deviations from normal morphology were found in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the test substance was found to be > 2000 mg/kg bw (i.e. > 1860 mg a.i./L) in male/female rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance (of ca. 93 % purity) in Tif: RAIf (SPF) rats according to OECD Guideline 401and EU Method B.1 in compliance with GLP. A group of 10 animals (5/sex/dose) received a single oral (gavage) dose of 2000 mg/kg bw of the test substance. No mortality was observed. Normal bodyweight gains were recorded in all the animals throughout the study. Piloerection, hunched posture and dyspnoea were seen within 1 h of dosing. The animals recovered within 5-6 d. Terminal necropsy findings were normal. Based on the findings of the study, the oral LD50 of the test substance was >2000 mg/kg bw (i.e. >1860 mg a.i./L) in male/female rats.
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