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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye 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:
2-benzoylbenzoic acid
EC Number:
201-612-2
EC Name:
2-benzoylbenzoic acid
Cas Number:
85-52-9
Molecular formula:
C14H10O3
IUPAC Name:
2-benzoylbenzoic acid

Test animals / tissue source

Species:
chicken
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
30 mg of test item after being reduced in fine powder
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180 and 240 min after post-treatment rinse.
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
Maximal mean
Value:
2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: corresponding to ICE class III
Irritation parameter:
fluorescein retention score
Run / experiment:
Mean
Value:
3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: correspondaing ti ICE class IV
Irritation parameter:
percent corneal swelling
Run / experiment:
Maximal mean
Value:
4
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: corresponding to ICE class I
Other effects / acceptance of results:
The combinaison of the three endpoints for the positive control was 3 x IV. Therefore, the positive control is classified as "corrosive / severe irritant", as expected.
The combinaison of the three endpoints for the negative control was 3 x I. Therefore, the positive control is classified as "No category", as expected.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combination of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combination leads to the category "No prediction can be made" as defined in the OCED guideline. Additional testing is required to establish a definitive classification.
Executive summary:

The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combination of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combination leads to the category "No prediction can be made" as defined in the OCED guideline. Additional testing is required to establish a definitive classification.