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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov-Dec 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: test report performed under GLP and according to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid
EC Number:
700-740-0
Cas Number:
1103234-56-5
Molecular formula:
C10H11F2NO4S
IUPAC Name:
2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid
Details on test material:
-Substance type: organic
-Physical state: white powder
-Storage condition of test material: at room temerature, protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Harlan LAboratories B.V., NM Horst, The Netherlands
-Age (when treated): 10 weeks

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Details on oral exposure:
Dose level (volume): 2000 mg/kg (10 mL/kg) body weight
Doses:
Single dose: 2000 mg/kg b.w.
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
The animals received a single dose of the test item by oral gavage administration 2000 mg/kg
body weight after being fasted for approximately 16 to 18 hours (access to water was permitted).
Food was provided again approximately 3 hours after dosing.
The dosing volume was 10 mL/kg body weight.

Viability I Mortality:
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.

Clinical Signs:
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, depending
on the occurrence of clinical signs of toxicity. Once
daily during days 2-15.
Body Weights:
On test days 1 (prior to administration), 8 and 15.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occurred
Clinical signs:
other: No clinical signs were recoreded throughout the entire observation period
Gross pathology:
No macroscopic abnormalities were noted

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of SAC-Sulfonamidsäure in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

Two groups, each consisting of three female RccHan:WIST (SPF) rats, were treated with SACSulfonamidsaure by a single oral gavage administration of 2000 mg/kg body weight. The test item was formulated in PEG 300 at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No intercurrent deaths occurred during the course of the study. No clinical signs were recorded throughout the entire observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of SAC-Sulfonamidsaure after single oral administration to female rats, observed over a period of 14 days, is: LD50 (female rat): greater than 2000 mg/kg body weight Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), SAC-Sulfonamidsaure is not classified with respect to acute oral toxicity in the rat.