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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
The study was performed in compliance with the following regulations or guidelines:
 OECD Guideline for the Testing of Chemicals No. 437 (updated 26 July 2013)
“Bovine Corneal Opacity and Permeability Assay”
 Method B.47 of Commission Regulation (EC) No. 440/2008
Deviations:
yes
Remarks:
Due to a failure to meet the assay acceptance criteria of the negative controls (opacity scores to high), it was necessary to repeat the test. Therefore the test performed on 11th January 2018 will not be reported and disregarded. Due to the Labtech LT-45
GLP compliance:
yes (incl. QA statement)

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 / tissue source

Species:
cattle

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 4.2
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No category. Not requiring classification to UN GHS or EU CLP.

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