Registration Dossier
Registration Dossier
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EC number: 287-574-8 | CAS number: 85536-87-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 20,1973 to January 4,1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
- EC Number:
- 287-574-8
- EC Name:
- 7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
- Cas Number:
- 85536-87-4
- Molecular formula:
- C20H19N3O11S3.xNa C20H(19-x)N3NaxO11S3
- IUPAC Name:
- 7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Orange 72/78
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 85 g
- Fasting period before study:16 hours before gavage application and 2 hours after
- Housing: in macrolon cages on soft wood granulate
- Diet : Altromin 1324 rat diet, ad libitum
- Water : ad libitum
Start of study: December 20, 1973
End of study: January 04, 1974
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% - Doses:
- 6300, 8000, 10000, 12500 mg/kg bw
- No. of animals per sex per dose:
- 10 female rats per dose level
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: multiple times on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes - Statistics:
- The LD50 and the limits of confidence were established in female animals on the basis of the Iethality rates by probit analysis.
(method of LINDNER and WEBER, and method of CAVALLI-SFORZA, programs supplied by Prakt. Mathematik, Hoechst Aktiengesellschaft)
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 8 377 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 7 741 - 9 065
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- 12 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 6 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 8000 mg/kg: 4 of 10 rats
10000 mg/kg: 9 of 10 rats
12500 mg/kg: 10 of 10 rat - Clinical signs:
- other: prone position and disorders of balance
- Gross pathology:
- orange discolouration of organs and connective tissue
- Other findings:
- The dye was in the feces and urine.
Any other information on results incl. tables
| Doses mg/kg |
concentrations in % | Mortality |
| 6300 | 25 | 0 of 10 rats |
| 8000 | 25 | 4 of 10 rats |
| 10000 | 25 | 9 of 10 rats |
| 12500 | 25 | 10 of 10 rats |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in this study the median lethal dose value (LD50) of Remazol Goldorange 3G was calculated by probit analysis for the female Wistar rat to be 8377 mg/kg body weight.
- Executive summary:
- Remazol Goldorange 3G was tested for acute toxic effects by oral administration in female Wistar rats only, as male animals did not show a higher sensitivity to the test substance. Lethality occurred up to day 3 of the study at 8000, 10000, and 12500 mg/kg bw. The animals showed prone position and disorders of balance. Development of body weight was not impaired in the surviving animals. The test substance was excreted with feces and urine. Necropsy of the deceased animals revealed orange discolouration of organs and connective tissue. The acute oral toxicity testing of Remazol Goldorange 3G in the female Wistar rat yielded a median lethal dose (LD50) of 8377 mg/kg body weight. The classification by “Handbook of Toxicology” describes the test dye as non toxic
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