Registration Dossier

Diss Factsheets

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS 870.1000
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)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)
EC Number:
626-424-1
Cas Number:
59572-10-0
Molecular formula:
C16H16O12S4.4Na
IUPAC Name:
1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent positive control
yes, concurrent negative control
Duration of treatment / exposure:
4 hours
Duration of post- treatment incubation (in vitro):
90 minutes
Number of animals or in vitro replicates:
Nine corneas

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Test Substance (PTSA)
Value:
7
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the results of this study, PTSA meets the requirements of EPA Category III and UN GHS No prediction can be made for the BCOP test.