Registration Dossier
Registration Dossier
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EC number: 220-028-9 | CAS number: 2610-11-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- other: no data
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
- EC Number:
- 220-028-9
- EC Name:
- Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
- Cas Number:
- 2610-11-9
- Molecular formula:
- C29H21N5O8S2.2Na
- IUPAC Name:
- disodium 7-benzamido-4-hydroxy-3-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif. RAI (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Body weight: from 160 to 180 g- Housing: 5 animals per cage Type 3 Macrolon- Diet: NAFAG, Gossau SG, rat food ad libitum- Water: tap water ad libitum ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 h light / 14 h dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 4640, 6000, 7750 and 10000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality for 4640 and 6000 mg/kg. Mortality started after 1 h after the exposure to 7750 mg/kg of the tested item.
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position andruffled fur.
- Gross pathology:
- No damage or changes to any organs.
- Other findings:
- No data.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The tested item was found to be non toxic for oral exposure with a LD50 ca 10000 mg/kg bw.
- Executive summary:
The acute oral toxicity of Direct Red 81 in rats of both sexes was assessed with this test over a period of 14 days.
The LD50 value was determined using different doses from 4640 mg/kg to 10000 mg/kg of active ingredient.
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