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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

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:
methyl 4-cyano-2-nitrobenzoate
EC Number:
610-840-5
Cas Number:
52449-76-0
Molecular formula:
C9H6N2O4
IUPAC Name:
methyl 4-cyano-2-nitrobenzoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3 (Animals of both sexes were used)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
On the day of treatment, 0.1 g of pulverized test substance was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
Observation period (in vivo):
7 days
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: 1h, 24h, 48h, 72h, 7days
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h, 24h, 48h, 72h, 7days
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: two animals score 0, one animal score 1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7days
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h, 72h, 7 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
Not irritating.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered to be not irritating to the rabbit eye.