Registration Dossier
Registration Dossier
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EC number: 240-267-2 | CAS number: 16102-99-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Nov - 07 Dec 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
- EC Number:
- 240-267-2
- EC Name:
- Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate
- Cas Number:
- 16102-99-1
- Molecular formula:
- C22H18N2O11S3.2Na C22H16N2Na2O11S3
- IUPAC Name:
- disodium 1-amino-9,10-dioxo-4-({4-[2-(sulfooxy)ethanesulfonyl]phenyl}amino)-9,10-dihydroanthracene-2-sulfonate
- 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: Hoechst AG
- Age at study initiation: f: ca. 7 weeks; m: ca. 8 weeks
- Weight at study initiation: f: 164 - 174 g (mean: 168 g); m: 177 - 181 g (mean: 179 g)
- Fasting period before study: 16 hours prior and 3-4 hours after gavage
- Housing: in groups of 5 animals
- Diet (e.g. ad libitum): ALTROMlN 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- 20 mL/kg in deionized water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- f: 5; m: 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: frequently on day 1, twice daily thereafter
- Frequency of weighing: weekly
- Necropsy of died animals performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- No clinical signs occured.
- Body weight:
- Body weight development was not impaired.
- Gross pathology:
- Normal state of organs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality occured among male and female rats in an OECD 401 limit test. The LD50 (rat) is > 2000 mg/kg bw.
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