Registration Dossier
Registration Dossier
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EC number: 947-115-0 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-07-15 to 2015-08-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay, Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of Disodium (sulphonatothio)acetate and sodium chloride
- EC Number:
- 947-115-0
- Molecular formula:
- C2H2Na2O5S2.NaCl
- IUPAC Name:
- Reaction mass of Disodium (sulphonatothio)acetate and sodium chloride
- Test material form:
- liquid
- Details on test material:
- Purity of Test material:
60.9 % Disodium (sulphonatothio)acetate
20.3 % NaCl
4.3 % Na2S2O3
0.6 % NasSO4
5.0 % H2O
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Sample 14/078 from Mollescal HW, charge 10924344R0
- Expiration date of the lot/batch: April 28, 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany<
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation:
- Fasting period before study: at least 16 hours
- Housing: Single housing (Makrolon cage, type III)
- Diet: ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5 and 3 g/100mL
- Amount of vehicle: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 300 mg/kg bw was chosen in the first step with 3 female animals. - Doses:
- 50, 300 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: shortly before administration (day 0), weekly thereafter and on the day of death or sacrifice moribund starting with study day 1.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In the 300 mg/kg bw test group all animals were found dead on study day 1 after administration. No mortality occurred in both 50 mg/kg bw test groups.
- Clinical signs:
- other: Impaired general state and piloerection was noted at hour 5 in all animals of the high dose group. Cowering position was additionally observed in two of these animals at the same time point. Impaired general state and piloerection was also noted in all an
- Gross pathology:
- The following macroscopic pathologic findings were observed in all animals of the 300 mg/kg bw test group which were found dead on study day 1:
Dark red, spotted discoloration of all lung lobes, red discoloration of the small intestine contents and light spotted discoloration of the liver.
There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period (50 mg/kg bw, 6 females).
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
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