Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
The following deviation to the Study Plan occurred: Based on current GLP guidance, at the time of issue/approval, the Study Plan did not contain sufficient information with regards test item identification. The required information is however included in
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chloro-5-sulphamoylbenzoic acid
EC Number:
214-882-1
EC Name:
4-chloro-5-sulphamoylbenzoic acid
Cas Number:
1205-30-7
Molecular formula:
C7H6O4NClS
IUPAC Name:
4-chloro-3-sulfamoylbenzoic acid
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System − Unclassified).