Registration Dossier
Registration Dossier
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EC number: 280-116-8 | CAS number: 83006-67-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- - Principle of test: oral
- Short description of test conditions: media for application: water; 10 rats per sex and dose; observation time: 14 days
- Parameters analysed / observed: intoxication symptoms, mortality - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 2,2'-[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthrylene)diimino]bis[5-tert-butylbenzenesulphonate]
- EC Number:
- 280-116-8
- EC Name:
- Disodium 2,2'-[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthrylene)diimino]bis[5-tert-butylbenzenesulphonate]
- Cas Number:
- 83006-67-1
- Molecular formula:
- C34H34N2O10S2.2Na
- IUPAC Name:
- Disodium 2,2'-[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthrylene)diimino]bis[5-tert-butylbenzenesulphonate]
- Test material form:
- solid
- Details on test material:
- Acid Green 81
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- TNO/W74
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Winkelmann; Borchen
- Age at study initiation: 9 weeks
- Weight at study initiation: 150 - 200g
- Fasting period before study: 16 hours before application and 4 hours after application
- Housing: Makrolon cage type III (groups of 5 animals)
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 12h/12h (light from 6 am to 6pm)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- DOSAGE PREPARATION: the test item was solved at ambient temperature in tap water.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of application: multiple observations; during 14 days observation: twice per working day, once on weekend and holiday; weekly weighing
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male
- 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
- Clinical signs:
- no clinical signs
- Body weight:
- not affected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for oral (gavage) toxicity to male rats was determined to be > 5000 mg/kg bw. The substance is not classifiable according to CLP criteria.
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