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EC number: 241-379-4 | CAS number: 17354-14-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Early study, no GLP, short report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
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
Test material
- Reference substance name:
- 1,4-bis(butylamino)anthraquinone
- EC Number:
- 241-379-4
- EC Name:
- 1,4-bis(butylamino)anthraquinone
- Cas Number:
- 17354-14-2
- Molecular formula:
- C22H26N2O2
- IUPAC Name:
- 1,4-bis(butylamino)anthraquinone
- Details on test material:
- technically pure
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: SPF-Zucht: Firma Gassner, Ottobrunn, Deutschland
- Age at study initiation: no data
- Weight at study initiation: male: ca 215 g; female: ca. 155 g
- Fasting period before study: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS : no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 or 16 % (w/v; suspension)
- Amount of vehicle (if gavage): max. ca. 8,6 mL
- Justification for choice of vehicle: the test material is insoluble in all possible vehicles
- Lot/batch no. (if required): no data
MAXIMUM DOSE VOLUME APPLIED: ca. 8,6 mL - Doses:
- 200 - 1600 - 3200 - 6400 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 6 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One male rat died about 7 days after treatment. The animal showed pneumonia during necropsy. The death was not considered as a consequence of treatment. Surviving animals also showed signs of pneumonia at necropsy.
- Clinical signs:
- other: Dyspnea and apathy were observed for 2 to 5 days.
- Gross pathology:
- The deceased animal showed pneumonia during necropsy. Surviving animals also showed signs of pneumonia at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw after single, oral gavage in the rat.
- Executive summary:
The acute oral toxicity of the test material was determined in Sprague-Dawley rats. The test material was suspended in an aqueous suspension of carboxymethyl-cellulose at 2 % (low dose) or 16 % (w/v; other doses). Doses employed were 200, 1600, 3200 and 6400 mg/kg applied orally by gavage.
The aproximate mean lethal dose (AID 50) was above 6400 rng/kg bw.
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