Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 437 (2009)
Principles of method if other than guideline:
Bovine Corneal Opacity and Permeability Test (BCOP-Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-Nitrotoluene-2-sulphonic acid
- Analytical purity:84.2 %
- Lot/batch No.:090330

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl of a 20% test-substance preparation


Results and discussion

Any other information on results incl. tables

The BCOP test showed the following results: The mean opacity change of the test-substance treated corneas was 143.4. The mean OD490 of the test-substance treated corneas determined as permeability parameter was 0.013. The In Vitro Irritancy Score (IVIS) of the test-substance treated corneas was calculated to be 143.6.

Based on the observed results and applying the evaluation criteria it was concluded, that 4-Nitrotoluene-2-sulphonic acid causes serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.

Applicant's summary and conclusion

Interpretation of results:
other: causes serious eye damage (in vitro irritancy score (IVIS) = 143.6)