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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

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:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
6-chloro-N-ethyl-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine
EC Number:
630-330-6
Cas Number:
21715-46-8
Molecular formula:
C17H18Cl2N2O
IUPAC Name:
6-chloro-N-ethyl-4-methyl-4-phenyl-4H-3,1-benzoxazin-2-amine
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
chicken

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
The test item D4223 was applied, as supplied, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds.
Duration of treatment / exposure:
10 seconds
Duration of post- treatment incubation (in vitro):
30, 75, 120, 180 and 240 minutes post-dose
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
maximal score
Value:
0.3
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
maximal score
Value:
1
Positive controls validity:
valid
Irritation parameter:
percent corneal swelling
Value:
1
Positive controls validity:
valid
Other effects / acceptance of results:
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.3, corresponding to ICE class I;
- mean score of fluorescein retention: 1.0, corresponding to ICE class II;
- maximal mean corneal swelling: 1%, corresponding to ICE class I.
The combination of the three endpoints for the test D4223 was 2 x I, 1 x II.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chicken eyes.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item D4223 does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category).
No signal word and hazard statement are required
Executive summary:

The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chicken eyes.

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item D4223 does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category).

No signal word and hazard statement are required