Registration Dossier
Registration Dossier
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EC number: 240-521-2 | CAS number: 16470-24-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 21 to October 5, 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]
- EC Number:
- 240-521-2
- EC Name:
- Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]
- Cas Number:
- 16470-24-9
- Molecular formula:
- C40H44N12Na4O16S4
- IUPAC Name:
- tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[bis(2-hydroxyethyl)amino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAif (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 to 8 weeks.
- Body weights at study initiation: males - 175 g; females - 176 g.
- Fasting period before study: overnight.
- Housing: in groups of 5 in Macrolon cages (type 3).
- Diet: rat food NAFAG No. 890 NAFAG Gossau SG, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C.
- Humidity: 55 ± 10 %.
- Photoperiod: 12 hours light per day.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 20 ml/kg body weight. - Doses:
- 5000 mg/kg body weight.
- No. of animals per sex per dose:
- 5 animals/sex
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: physical condition and rate of deaths were monitored throughout the whole observation period; body-weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes; all animals were submitted to a necropsy, whenever they died, survivors at the end of the observation period.
- Other examinations performed: gross examination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured.
- Clinical signs:
- other: Dyspnoea, exophthalmos, ruffled fur reported, diarrhoea and curved body position were observed. Nevertheless all symptoms are recovered within 9 days.
- Gross pathology:
- No compound related gross organs changes were reported.
Any other information on results incl. tables
| Signs and symptoms | hrs | Days | ||||||||||||||||
| 1 | 2 | 3 | 5 | 24 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | |
| Sedation | ||||||||||||||||||
| Dyspnoea | + | + | + | + | + | + | + | + | + | + | + | + | ||||||
| Dacryorrhoea | ||||||||||||||||||
| Chromodacryorrhoea | ||||||||||||||||||
| Rinorrhoea | ||||||||||||||||||
| Epistaxis | ||||||||||||||||||
| Exophthalmos | + | + | + | + | + | + | + | |||||||||||
| Salivation | ||||||||||||||||||
| Ruffled fur | ++ | ++ | ++ | ++ | + | + | + | + | + | + | + | |||||||
| Pallor | ||||||||||||||||||
| Cyanosis | ||||||||||||||||||
| Diarrhoea | + | + | ||||||||||||||||
| Body position (ventral) | ||||||||||||||||||
| Body position (lateral) | ||||||||||||||||||
| Body position (curved) | + | + | + | + | + | + | + | + | + | + | ||||||||
| Ataxia | ||||||||||||||||||
| Trismus | ||||||||||||||||||
| Tremor | ||||||||||||||||||
| Tonic clonic muscle spasms | ||||||||||||||||||
| Convulsions | ||||||||||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information According to the CLP Regulation. Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 5000 mg/kg bw
- Executive summary:
Method
The acute oral toxicity of the test compound in rats of both sexes was tested at the single concentration of 5000 mg/kg bw and observed over a period of 14 days.
Results
The LD50 is greater than 5000 mg/kg bw.
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