Registration Dossier
Registration Dossier
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EC number: 280-427-9 | CAS number: 83400-12-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1973
- 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:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only female rats used
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 5-(benzoylamino)-3-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, lithium sodium salt
- EC Number:
- 280-427-9
- EC Name:
- 5-(benzoylamino)-3-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, lithium sodium salt
- Cas Number:
- 83400-12-8
- Molecular formula:
- C32 H21 Cl F2 N6 O11 S3 . x Li . x Na C32H(21-x-y)ClF2Li(x)N6Na(y)O11S3
- IUPAC Name:
- 5-(benzoylamino)-3-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, lithium sodium salt
- Test material form:
- solid
- Details on test material:
- Reactive Red 159
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breed
- Weight at study initiation: 150 to 200 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 0.5% in H2O
- Details on oral exposure:
- Dose applied: 30 mL/kg
- Doses:
- 9, 10, 11, 11.5, 12 g/kg
- No. of animals per sex per dose:
- 10 females
- Control animals:
- no
- Details on study design:
- Observation period: 14 days
- Statistics:
- Probit-Analyse (Fink und Hund, Arzneimittelforsch. 15, 1965, 624)
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 11 264 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 10 735 - < 12 107
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 7 209 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 9 g/kg: 1/10
10 g/kg: 2/10
11 g/kg: 7/20
11.5 g/kg: 11/20
12 g/kg: 8/10 - Clinical signs:
- Dead occurred within 5 hours to 2 days after application
Survivors: sedation, prone position, shaggy fur - Body weight:
- no data
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (oral, female rats) is far above 5000 mg/kg. The substance is not acutely toxic and does not meet the criteria for classification according to the CLP Regulation.
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