Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Remarks:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
The toxicity observed in this study is most likely caused by the relatively high reactivity of the diiodofluoroalkane. The PDA-3 is smaller than the primary components of the PDA-4,6 mixture, and the dediiodination reaction most likely occurs at somewhat faster rate than the PDA-4,6, but the reaction occurs in both. Because of this, the data for PDA-3 is a conservative estimation of the toxicity resulting from PDA-4,6 and so it is reasonable to read across to it.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

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)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
422-91-3
Test material form:
liquid
Details on test material:
- Purity: Not reported
- CAS: 422-91-3

Test animals / tissue source

Species:
cattle

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 µL
Duration of post- treatment incubation (in vitro):
2 hours
Number of animals or in vitro replicates:
5

Results and discussion

In vitro

Results
Irritation parameter:
other: In vitro irritation score
Value:
34.2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
pH 5

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The in vitro score for the test substance was 34.2. Positive indication of irritation, but not sufficient to derive a classification.
Executive summary:

An in vitro eye irritation test was performed in accordance with OECD Guideline 437. The in vitro score for the test substance was 34.2. Since the results of the positive control fell within two standard deviations of the historical mean (within a range of 39.2-63.5), the assay was considered valid. The test substance is considered to be a moderate eye irritant.

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