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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
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)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Test material form:
liquid: viscous
Specific details on test material used for the study:
Solvent-free Dabco TMR Batch# meyersl.20160601

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Three bovine corneas per group were dosed with 0.75 ml of Solvent-free Dabco TMR
Duration of treatment / exposure:
10 minutes
Duration of post- treatment incubation (in vitro):
N/A
Number of animals or in vitro replicates:
Three bovine corneas per group

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
34.12
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
1
Value:
15.67
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: Corrected Mean Optical Density
Run / experiment:
1
Value:
1.23
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Based on an In Vitro Irritatancy Score between 3 and 55, no prediction can be made for the UN GHS
categorization of the test article as defined in OECD Guideline #437.

According to EURL ECVAM DB-ALM Protocol No. 127, Solvent-free Dabco TMR Batch# meyersl.20160601 is considered to be a moderate eye irritant.