Registration Dossier
Registration Dossier
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EC number: 247-640-9 | CAS number: 26381-41-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from opinions on health and safety risks (chemical, biological, mechanical and other physical risks)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: refer below principle
- Principles of method if other than guideline:
- Study conduct to determine the acute toxic effects by oral route of test substance Basic Brown 16 in male and female CFY rat.
- GLP compliance:
- no
- Test type:
- other: no data
- Limit test:
- no
Test material
- Reference substance name:
- [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- EC Number:
- 247-640-9
- EC Name:
- [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- Cas Number:
- 26381-41-9
- Molecular formula:
- C19H21N4O.Cl
- IUPAC Name:
- 8-[(4-aminophenyl)diazenyl]-7-hydroxy-N,N,N-trimethylnaphthalen-2-aminium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride- Molecular formula (if other than submission substance): C19-H21-N4-O.Cl - Molecular weight (if other than submission substance): 356.855- Smiles notation (if other than submission substance): c1(\N=N\c2ccc(cc2)N)c2cc([N+](C)(C)C)ccc2ccc1O.[ClH-]- Substance type: Organic - Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: methylcellulose
- Details on oral exposure:
- VEHICLE- Concentration in vehicle:0, 0.1, 1.0, 2.0 and 4.0 g/kg bw in volumes of 1.0 to 40 ml/kg- Amount of vehicle (if gavage):40 ml/kg
- Doses:
- 0, 0.1, 1.0, 2.0 and 4.0 g/kg bw
- No. of animals per sex per dose:
- 2 male + 2 female rats
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing:daily- Necropsy of survivors performed: no- Other examinations performed: mortality and clinical abnormalities,Body weights and macroscopic observations.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 - 4 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities
- Clinical signs:
- other: Signs of reaction to treatment, observed shortly after dosing, included piloerection and abnormal body carriage (hunched posture).
- Gross pathology:
- No abnormalities were recorded at autopsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The LD50 was reported to be between 2000 and 4000 mg/kg bw.
- Executive summary:
Groups of 2 male and 2 female rats received a single oral dose of 0.1, 1.0, 2.0 or 4.0 g/kg bw. Control animals received 1% aqueous methylcellulose in a volume of 40 ml/kg. The animals were observed daily for 14 days for mortality and clinical abnormalities. Body
weights and macroscopic observations were recorded, but histological examinations were not performed.
Within one week of dosing, all animals treated at 4.0 g/kg bw died, one female died after a dose of 1.0 g/kg and one after a dose of 2.0 g/kg bw; no male rats died at doses of 1 or 2 g/kg bw. There were no mortalities at 0.1 g/kg. Signs of reaction to treatment, observed shortly after dosing, included piloerection and abnormal body carriage (hunched posture). The bodyweight gain of surviving treated animals was similar to controls and no abnormalities were recorded at autopsy.
The LD50 was reported to be between 2000 and 4000 mg/kg bw.
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