Registration Dossier
Registration Dossier
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EC number: 275-654-5 | CAS number: 71598-17-9
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only basic data given, equivalent to OECD guideline, no GLP study, the test substance was tested in a different composition as compared to the composition of the registered substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
- EC Number:
- 275-654-5
- EC Name:
- 2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
- Cas Number:
- 71598-17-9
- Molecular formula:
- C21H25N2.C2H3O2
- IUPAC Name:
- 2-{2-[4-(dimethylamino)phenyl]vinyl}-1,3,3-trimethyl-3H-indolium acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 197 g, female: 164 g
- Diet: Herilan MRH-Haltung, Alleinfutter für die Haltung von Mäusen, Ratten und Hamstern, Heinrich EGGERSMANN KG, Rinteln
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
VEHICLE
- Amount of vehicle: 0.5 % CMC in distilled water - Doses:
- 316, 464, 681, 1000, 1470, 2150 and 3160 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 150 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 493 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: recalculated based on dye content of registered substance (ca. 56% w/w) versus tested material (24% w/w)
- Mortality:
- 681 mg/kg: 2 of 10 animals died
1000 mg/kg: 2 of 10 animals died
1470 mg/kg: 9 of 10 animals died
2150 mg/kg: 10 of 10 animals died
3160 mg/kg: 10 of 10 animals died - Clinical signs:
- other: Death and poor general state on the 1st day of the study; nonspecific signs; at the highest dose, narcotic-Iike state with absence of pain and corneal reflexes.
- Gross pathology:
- Animals that died:
Heart: Acute dilatation and acute passive hyperemia
Intestines: Slightly diarrheal contents
Urine: Slightly colored
Sacrificed animals:
Organs: No abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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