Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
2017
Report date:
2017

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:
adopted in 2013
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-bromo-4-fluorophenyl)acetamide
EC Number:
600-141-3
Cas Number:
1009-22-9
Molecular formula:
C8H7BrFNO
IUPAC Name:
N-(2-bromo-4-fluorophenyl)acetamide

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 750 μL
- Concentration (if solution): 20% in physiological saline

VEHICLE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration: 0.9% (v/w)

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% in physiological saline
Duration of treatment / exposure:
4 h
Observation period (in vivo):
not applicable
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Remarks:
mean value of 3 corneas
Run / experiment:
4 h exposure
Value:
0.763
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
mean value of 3 corneas
Run / experiment:
4 h exposure
Value:
0.718
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Remarks:
mean value of 3 corneas
Run / experiment:
4 h exposure
Value:
0.003
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
In this bovine cornea opacity test, 3 coreas each were exposed to the test substance, the negative or the positive control for 4 h, respectively. Afterwards, corneal injury was assessed by evaluating the opacity and permeability of the cornea. The calculated in vitro irritancy score (IVIS) revealed a mean value of 0.763, which was below the threshold for irritation of 3 defined in the OECD 437. Thus, the test substance does not show irritant properties towards the eye and no classification is required according to EU classification criteria.