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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Planned changes to the study plan can be made at the discretion of the study director and will be agreed with the Sponsor. Detailed descriptions of all study plan amendments will be effective at the time of study director’s signature. All such amedments w
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Cyano-3-(3,4-dimethoxyphenyl)propanoic acid
EC Number:
611-278-3
Cas Number:
55502-61-9
Molecular formula:
C12H13NO4
IUPAC Name:
2-Cyano-3-(3,4-dimethoxyphenyl)propanoic acid
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0.67 - <= 3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: In one rabbit full inspection was not possible at 48h. At both 24 and 72 hours, the coreneal and iris scores were zero, so although the eye was closed at 48 hours, it was assumed that therw were no corneal or iris effects at the 48 hour time point.
Remarks:
In one rabbit full inspection was not possible at 48h. At both 24 and 72 hours, the coreneal and iris scores were zero, so although the eye was closed at 48 hours, it was assumed that therw were no corneal or iris effects at the 48 hour time point.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: In one rabbit full inspection was not possible at 48h. At both 24 and 72 hours, the coreneal and iris scores were zero, so although the eye was closed at 48 hours, it was assumed that therw were no corneal or iris effects at the 48 hour time point.
Remarks:
In one rabbit full inspection was not possible at 48h. At both 24 and 72 hours, the coreneal and iris scores were zero, so although the eye was closed at 48 hours, it was assumed that therw were no corneal or iris effects at the 48 hour time point.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 2 - <= 2.67
Max. score:
2.67
Reversibility:
fully reversible
Remarks on result:
other: mean value could not be calculated because redness was not observable at 48 hours.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
The test item Cianacido, applied to the rabbits eye mucosa, caused significant conjunctival and corneal irritant effects, corneal opacity in one rabbit but no iris effects. The effects were reversible within three weeks. The severity prevented full scoring in one rabbit but for classification according to the EC criteria, the test item should be classified as H319 on basis of the observed conjunctival irritation.