Registration Dossier
Registration Dossier
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EC number: 228-794-6 | CAS number: 6359-10-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2010-02-23 to 2010-05-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test has a reliability of 1 but was only included as "other information" in the dossier since only a aqueous formulation containing 6.3 % test item was tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008-05-30
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 2-(11-oxido-3-oxo-3H-dibenzo[c,h]xanthen-7-yl)benzoate
- EC Number:
- 228-794-6
- EC Name:
- Disodium 2-(11-oxido-3-oxo-3H-dibenzo[c,h]xanthen-7-yl)benzoate
- Cas Number:
- 6359-10-0
- Molecular formula:
- C28H14Na2O5
- IUPAC Name:
- disodium 2-(11-oxido-3-oxo-3H-dibenzo[c,h]xanthen-7-yl)benzoate
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Disodium phthalate
- EC Number:
- 240-106-6
- EC Name:
- Disodium phthalate
- Cas Number:
- 15968-01-1
- Molecular formula:
- C8H6O4.2Na
- IUPAC Name:
- disodium phthalate
- Reference substance name:
- Oxydipropanol
- EC Number:
- 246-770-3
- EC Name:
- Oxydipropanol
- Cas Number:
- 25265-71-8
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 1,1'-oxydipropan-1-ol
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one
- EC Number:
- 220-120-9
- EC Name:
- 1,2-benzisothiazol-3(2H)-one
- Cas Number:
- 2634-33-5
- Molecular formula:
- C7H5NOS
- IUPAC Name:
- 1,2-benzisothiazol-3(2H)-one
- Details on test material:
- - Lot no: 10/11/09
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst, Netherlands
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 10 weeks
- Weight at study initiation: 184.3 - 191.0 g
- Fasting period before study: overnight fasting period prior to intubation and approximately 3-4 hours post dose
- Housing: In groups of three in Makrolon type-4 cages with wire mesh top
- Diet: Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 60/09 (Provimi Kliba AG, 4303 Kaiseraugst, Switzeiland), ad libitum
- Water: Community tap water from Füllinsdorf ad libitum
- Acclimation period: Under laboratory conditions, after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 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:
- VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. A 20 % preparation in water (w/w) resulted in a dark blue solution that was considered orally applicable.
- Purity: purified water was prepared at Harlan Laboratories Ltd. (deionised water which was processed and treated by the PURELAB Option-R unit, which links four purification technologies: reverse osmosis, adsorption, ion-exchange and photo oxidation). - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily during the acclimatization period, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (in common with the clinical signs) and twice daily during days 2-15. Weighing was performed on test days 1 prior to administration, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 126 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No intercurrent deaths occrured during the course of the study.
- Clinical signs:
- No clinical signs were observed throughout the entire observation period.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were recorded at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo acute oral toxicity study (Acute Toxic Class Method) in rats according to OECD Guideline 423, an LD50 of > 2000 mg/kg bw was determined.
- Executive summary:
In the present study the acute toxic effects of an aqueous formulation containing 6.3 % test item were investigated after a single peroral administration to rats. The investigations were performed in accordance with the OECD Guideline 423. The test item was (suspended in deionised water) administered once orally via gavage to female Wistar HccHan (SPF) rats (dose volume was 10 mL/kg bw). Dosing was performed sequentially to groups of 3 animals starting at 2000 mg/kg bw. Body weight was determined before administration, 7 and 14 days after the administration (p.a.). Clinical observations were performed at least once per day during the 14 days observation period and all animals were sacrificed and necropsied at the end of the observation period.
At a dose of 2000 mg/kg bw no clinical signs of the test substance were noted in life and post mortem. No mortality occurred. No macroscopic findings were recorded at necropsy. The weight was in the normal strain specific range. As no animals died, the oral LD50, was determined to be > 2000 mg/kg body weight.
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