Registration Dossier
Registration Dossier
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EC number: 944-086-6 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- pre-dates GLP regulation
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
- EC Number:
- 249-352-9
- EC Name:
- Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
- Cas Number:
- 28983-56-4
- Molecular formula:
- C37H29N3O9S3.2Na
- IUPAC Name:
- Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 10 female SPF-\!lstar-Rats , Strain Hoe: WlSKf(SPF 7:)
Weight: 160- 178 g (Average: 166 g)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil; 25 % suspension w/v
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- Single application by gavage
Observation period: 14 days
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: squatting posture, piloerection, accelerated respiration
- Gross pathology:
- no adverse findings
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was above 5000 mg/kg bw in female Wistar rats after single gavage
- Executive summary:
The test item was administered once by gavage as a 25 % suspension in sesame oil (w/v) to ten female Wistar rats. Afterwards anmilas showed squatting posture, piloerection and accelerated respiration. Observations were recorded for 14 days before a gross necropsy was performed. No pathological changes were observed at the end of the study.
The acute oral LD50 was above 5000 mg/kg bw in female Wistar rats after single gavage.
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