Registration Dossier
Registration Dossier
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EC number: 235-628-6 | CAS number: 12392-64-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study following official guidelines, GLP compliant, performed on a similar substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 278-127-8
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)
- Molecular formula:
- C40H22CrN4O10S2.H.2Na
- IUPAC Name:
- Trisodium bis[(E)-3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonate]chromate(3-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- The substance is the trisodium form of the target substance (disodium form)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Age at study initiation: 8 weeks for male, 9-10 weeks for female- Weight at study initiation: average 199g for male and average 173g for female- Acclimation period: 5 days adaptationThe female were nulliparous and non-pregnant.5 animals per sex were used
Administration / exposure
- Doses:
- single oral administration equal to 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex
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 was observed
- Clinical signs:
- other: After single-dosing of 2000 mg / kg no poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after the administration-of the tested substance a corresponding blue color of the dye administered was found in the faece
- Gross pathology:
- pathologically unremarkable
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The substance was tested following OECD 401 for acute oral toxicity showing a LD50 > 2000 mg/kg.
- Executive summary:
The substance was tested for acute toxicological studies in male and female wistar rats with single oral administration.
The LD50 (LD0) was found to be for male and female rat greater than 2000 mg/ kg. The administered dose resulted in blue dyed faeces. Poisoning phenomena were not observed. Body weight was not influenced in male and female rats. No mortality was observed. All animals were pathologically unremarkable.
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