Registration Dossier
Registration Dossier
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EC number: 248-421-0 | CAS number: 27344-41-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24, 1987
- GLP compliance:
- yes
- Remarks:
- Research & Consulting Company AG, CH-4452 Itingen, Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
- EC Number:
- 248-421-0
- EC Name:
- Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
- Cas Number:
- 27344-41-8
- Molecular formula:
- C28H22O6S2.2Na
- IUPAC Name:
- disodium 2,2'-(biphenyl-4,4'-diyldiethene-2,1-diyl)dibenzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): FAT 65029/G
- Physical state: powder
- Analytical purity: approx. 90%,
- Impurities (identity and concentrations): 7% NaCl, 3% H20
- Lot/batch No.: EN 372980, Op. 247/248
- Expiration date of the lot/batch: stable; expiration date: July, 1992
- Storage condition of test material: in the original container, protected from light at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 191 - 200 g; females: 166 - 179 g
- Fasting period before study: 12-18 hours
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml at 2000 mg/kg
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times during test day 1, and daily during days 2 - 15. Weighing: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death, toxicity was estimated without use of a statistical model.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: No clinical signs were observed during the study period.
- Gross pathology:
- No macroscopical organ findings were observed.
Applicant's summary and conclusion
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