Registration Dossier
Registration Dossier
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EC number: 240-245-2 | CAS number: 16090-02-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
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:
- Rats were dosed at concentrations of 3170, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 day post-treatment period in order to evaluated the substance acute oral toxicity.
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- EC Number:
- 240-245-2
- EC Name:
- Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- Cas Number:
- 16090-02-1
- Molecular formula:
- C40H38N12Na2O8S2
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis{5-[(4-anilino-6-morpholin-4-yl-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
- Weight at study initiation: 160 to 180 g.
- Fasting period before study: the rats were starved during one night before starting the treatment.
- Housing: segregated and housed in MacroIon cages (Type 3) in groups of 5.
- Diet: ad libitum, rat food, NAFAG, Gossau SG.
- Health: healtly rats.
- Water: ad libitum.
- Acclimatization: at leas 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: approx. 55 ± 5 %.
- Photoperiod: 14 hours light cycle day.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2%
- Details on oral exposure:
- TEST SOLUTION
- Preparation: before treatment the suspension was homogeneously dispersed with an Ultra-Turrax.
- During treatment: the suspension was kept stable with a magnetic stirrer. - Doses:
- 3170, 4640, 6000, 7750 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 20 males and 20 females; 5 x sex x dose.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes; survivors killed and autopsied after an observation period of 14 days. - Statistics:
- LD50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 7 562 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 6 651 - 8 598
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved or ventral position and ruffled fur. The survivor animals recovered within 7 to 8 days.
- Gross pathology:
- No substance related gross organ changes were seen.
Any other information on results incl. tables
Rate of deaths
| Dose mg/kg |
Conc. % of formulation | N. of animals | Died within | ||||||||||
| 1 hr | 24 hrs | 48 hrs | 7 days | 14 days | |||||||||
| M | F | M | F | M | F | M | F | M | F | M | F | ||
| 3170 | 30 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 4640 | 50 | 5 | 5 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
| 6000 | 50 | 5 | 5 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 |
| 7750 | 50 | 5 | 5 | 0 | 0 | 3 | 2 | 3 | 2 | 3 | 2 | 3 | 2 |
| 10000 | 50 | 5 | 5 | 1 | 2 | 4 | 5 | 4 | 5 | 4 | 5 | 4 | 5 |
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: 7562 (95 % CL: 6651-8598) mg/kg bw
- Executive summary:
Method
Rats were dosed at concentrations of 3170, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 day post-treatment period in order to evaluated the substance acute oral toxicity.
Result
LD50: 7562 (95 % CL: 6651-8598) mg/kg bw.
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved or ventral position and ruffled fur. The survivor animals recovered within 7 to 8 days.
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