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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD-guidelines.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-2,3-dihydro-1H-indol-2-one
EC Number:
930-401-4
Cas Number:
1383706-71-5
Molecular formula:
C13H11FN4O3
IUPAC Name:
3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-2,3-dihydro-1H-indol-2-one

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1d
Remarks on result:
other: in respect of the result 1 h post application
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1d
Remarks on result:
other: in respect of the result 1 h post application
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1d
Remarks on result:
other: in respect of the result 1 h post application
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 1d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1d
Remarks on result:
other: no chemosis at animal #2 and #3
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 1h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 1d
Irritant / corrosive response data:
First animal clinical observation:
At one hour after treatment, conjunctival redness (score 2), chemosis (score 1) and discharge (score 3) were noted. Residual test item was noted on the eye. Test item staining was also noted around the eye.
At 24, 48 and 72 hours after treatment, there were no clinical signs, and no conjunctival effects observed.
As there were no clinical signs observed, therefore this animal was euthanized after the 72 hours observation.
Second animal clinical observation:
At one hour after treatment, conjunctival redness (score 2) and discharge (score 3) were noted. Residual test item was noted on the eye. Test item staining was also noted around the eye.
At 24, 48 and 72 hours after treatment, there were no clinical signs, and no conjunctival effects observed.
As there were no clinical signs observed, therefore this animal was euthanized after the 72 hours observation.
Third animal clinical observation:
At one hour after treatment, conjunctival redness (score 2) and discharge (score 3) were noted. Residual test item was noted on the eye. Test item staining was also noted around the eye.
At 24, 48 and 72 hours after treatment, there were no clinical signs, and no conjunctival effects observed.
As there were no clinical signs observed, therefore this animal was euthanized after the 72 hours observation.
Other effects:
Negative fluorescein staining was observed on the cornea of the treated eye in all animals during the observation period.
During the study, the control eye of each animal was symptom-free.
The general state and behaviour of animals were normal throughout the study period.
There were no notable body weight changes during the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item applied to the rabbits’ eye mucosa, caused conjunctivae effects. The effects were fully reversible within 24 hours.
The study result triggers the following classification/labelling:
- EU directive 1999/45/EC: none
- Regulation (EC) No 1272/2008 (CLP): none