Registration Dossier
Registration Dossier
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EC number: 219-708-8 | CAS number: 2503-73-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.-03.1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study report contains the limited information on the test conditions because the study has been performed in 1991 . However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Tetrasodium 2-[[4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulphonato-2-naphthyl]azo]-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
- EC Number:
- 219-708-8
- EC Name:
- Tetrasodium 2-[[4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulphonato-2-naphthyl]azo]-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
- Cas Number:
- 2503-73-3
- Molecular formula:
- C42H29N7O13S4.4Na
- IUPAC Name:
- tetrasodium 2-[[4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulphonato-2-naphthyl]azo]-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Direct Blue 78- Physical state: solid, powder- Analytical purity: 95% (w/w)- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 10% (w/w)- Lot/batch No.: 7013/207- Expiration date of the lot/batch: unlisted- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.
Constituent 1
impurity 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL- Number of animals: 5- Weight at study initiation: 264-294 g- Housing: 1 animal per cage
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE - Area of exposure: 4x6 cm, depilated skin - Type of wrap if used: mull, aluminium fall, plaster bandage REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 24h TEST MATERIAL - Amount(s) applied: 5g/kg - For solids, paste formed: yes (substance+ 1,5 ml water)
- Duration of exposure:
- 24h
- Doses:
- 5.0 g/kg
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: after 14 days - Necropsy of survivors performed: yes - Other examinations performed: clinical observation of animals was practised every day,
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Mortality:
- no mortality during test
- Clinical signs:
- other: No clinilac signs after aplication
- Gross pathology:
- After 14 days all animals were sacrificed. No macroscipical findings were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not absorbed in a toxic quantity.
- Executive summary:
The substance is not absorbed in a toxic quantity.
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