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EC number: 273-402-9 | CAS number: 68959-19-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-11-01 to 1983-01-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 5000 mg/kg bw, instead of 2000 mg/kg bw, was administered as limit dose.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate
- EC Number:
- 273-402-9
- EC Name:
- Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate
- Cas Number:
- 68959-19-3
- Molecular formula:
- C17H16Cl2N4O5S2.Na
- IUPAC Name:
- sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: males: 9 weeks, females: 14 weeks
- Weight at study initiation: males: 186 to 196 g, females: 165 to 174 g
- Fasting period before study: 16 hours before and 4 hours after treatment
- Housing: Animals were kept in Makrolon cages type III on dust-free wood granules
- Diet (e.g. ad libitum): Altromin R 1324 from Altromin GmbH, Lage, Germany; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- tap water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL kg bw
DOSAGE PREPARATION: The test item was formulated in tap water at room temperature
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: On the day of application animals were observed multiple times. During the 14 days observation period animals were observed twice daily (once at weekend and holidays). Type, onset, duration and intensity of clinical symptoms were examined
- Frequency of weighing: Animals were weighed on the day of application, after one week and after 14 days
- Necropsy of survivors performed: yes, on a random basis - Statistics:
- not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality observed
- Clinical signs:
- No effects observed
- Body weight:
- No effects observed
- Gross pathology:
- No effects observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats, no mortality has been observed at a dose of 5000 mg/kg bw. Hence, the LD50 value can be considered to be greater than 5000 mg/kg bw. The substance is not classifiable according to GHS criteria.
- Executive summary:
In an acute oral toxicity study, groups of fasted young adult Wistar rats (5/sex) were given a single oral dose of the test item in water at a dose of 5000 mg/kg bw and observed for 14 days. All animals survived until the end of the study. No clinical signs and/or effects on body weight were observed. Gross pathology performed on certain animals revealed no adverse signs. Based on the results, the oral LD50 in both male and female rats can be considered to be greater than 5000 mg/kg bw.
Based on these results, no classification for acute oral toxicity is warranted according to CLP criteria.
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