Registration Dossier
Registration Dossier
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EC number: 278-145-6 | CAS number: 75234-41-2
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: no GLP; short report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-dates GLP regulation
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- EC Number:
- 278-145-6
- EC Name:
- Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- Cas Number:
- 75234-41-2
- Molecular formula:
- C40H26CrN8O14S2.3Na
- IUPAC Name:
- trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd. Margate UK
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: 70 to 90 g
- Fasting period before study: 21 h
- Housing: no data
- Diet (e.g. ad libitum): ad ibitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2 C
- Humidity (%): ca 47%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40 %
- Justification for choice of vehicle: Water is the vehicle of joice whenever possible.
MAXIMUM DOSE VOLUME APPLIED: 12.5 ml/kg - Doses:
- 0 mg/kg bw ( Control)
5000 mg/kg bw (treated) - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency ofweighings: days 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 5 000
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred
- Mortality:
- None
- Clinical signs:
- other: Piloerection, hunched posture, and abnormal gait (waddling) occurred shortly after dosing. Piloerection was abserved also in the control group.
- Gross pathology:
- No abnormal findings
- Other findings:
- none.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral gavage of 5000 mg/kg bw of the test material did not cause mortality in male and female rats.
- Executive summary:
The oral gavage of 5000 mg/kg bw of the test material did not cause mortality in male and female rats. Clinical signs were limited to temporary piloerection hunched posture and abnormal gait shortly after treatment. No adverse effects on body weights or the macroscopic appearance of organs were detected.
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