Registration Dossier
Registration Dossier
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EC number: 229-129-2 | CAS number: 6416-66-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1975
- 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:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Similar to OECD 401, a single dose of the substance was administered to rats by gavage
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- EC Number:
- 229-129-2
- EC Name:
- Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- Cas Number:
- 6416-66-6
- Molecular formula:
- C29H20ClN3O10S3.2Na
- IUPAC Name:
- Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Number of animals: 10 (5 female and 5 male)- Age at study initiation: 6- 7 weeks- Weight at study initiation: 225 g (male), 190 g (female)- Housing: singly caged- Diet : commercial pelletted diet (added with vit.E) ad libitum- Water : ad libitum for all test durationENVIRONMENTAL CONDITIONS- Temperature (°C): 21°C ± 2°- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- A 25 w/v i solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours
- Doses:
- Dose rate of 20ml/kg (equivalent to 5g/kg. compound)
- Details on study design:
- - Duration of observation period following administration: 14 days- Other observation: clinical symptoms- Autopsy performed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death
- Clinical signs:
- other: No clinical symptoms
- Gross pathology:
- No change in organs or tissue
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 5000 mg/kg body weight
- Executive summary:
The determination of oral toxicity of the substance was determined in an, but no guideline is available and the test was not performed on GLP. The test substance was tested in a single dose (5000 mg/kg bw) on rats. The animals were observed for 14 days.
The acute oral median lethal dose LD50 in rats in > 5000 mg/kg body weight.
No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
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