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EC number: 269-941-4 | CAS number: 68391-30-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON Basic Red 76
- Author:
- Scientific Committee on Consumer Safety SCCS
- Year:
- 2 011
- Bibliographic source:
- Scientific Committee on Consumer Safety SCCS - adopted at its 10th plenary meeting of 22 March 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- not specified
- Test type:
- other: No data
Test material
- Reference substance name:
- [7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride
- EC Number:
- 269-941-4
- EC Name:
- [7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride
- Cas Number:
- 68391-30-0
- Molecular formula:
- C20H22ClN3O2
- IUPAC Name:
- 7-hydroxy-8-[(2-methoxyphenyl)diazenyl]-N,N,N-trimethylnaphthalen-2-aminium chloride
- Reference substance name:
- Basic Red 76
- IUPAC Name:
- Basic Red 76
- Details on test material:
- - Name of test material (as cited in study report):Basic Red 76- Molecular formula (if other than submission substance):C20H22Cl1N3O2- Molecular weight (if other than submission substance):371.87- Substance type:Organic- Physical state:Solid- PurityDetermined by HPLC > 98.1 % (AUC, HPLC), - Impurities (identity and concentrations):water content = 5.1%(w/w); Monomethyl sulphate 11.8% (w/w); o-anisidine = 5ppm; Sulphated ash 0.4% (w/w); Chloride 1.6% (w/w); Sodium = 630 ppm; Calcium = 590 ppm; Saccharose = 25.8%(w/w)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLEConcentration in vehicle: Basic Red 76 in propylene glycolLot/batch no. (if required): 00506441 01 (of the target)MAXIMUM DOSE VOLUME APPLIED: 2000mg/kgbw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Groups of 3 male and 3 female rats
- Control animals:
- not specified
- Details on study design:
- Duration of observation period following administration: 14 days (or other?): 15 daysFrequency of observations and weighing: DailyNecropsy of survivors performed: yes/no: yes Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Hunched posture was noted in one female and 3 males on day 1. Red staining of the back and/or snout and/or head was noted in 1 female and 2 males between days 1 and 11.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- Red and/or yellow faeces and/or yellow urine were seen among the animals on days 2 and/or 3.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76. Groups of 3 male and 3 female rats received a single oral dose of 2000 mg/kg bw.The LD50 was reported to be greater than 2000 mg/kg bw.
- Executive summary:
An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76.
Basic Red 76 was administered by oral gavage to a group of three female Wistar rats and subsequently to a group of three male Wistar rats at 2000 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
No mortality occurred. Hunched posture was noted in one female and 3 males on day 1. Red staining of the back and/or snout and/or head was noted in 1 female and 2 males between days 1 and 11. Red and/or yellow faeces and/or yellow urine were seen among the animals on days 2 and/or 3. The mean body weight gain over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
The LD50 was reported to be greater than 2000 mg/kg bw
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