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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Concerning: Expiry date of Freund’s complete adjuvant (FCA) According to the Study Plan: 30 April 2009 Deviation: 30 April 2008 Reason for the Deviation: miswritten Presumed Effect on the Study: None
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method does not need to be conducted since there is a in vivo skin sensitization study available according to previous legislation.

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Positive response was not observed
There were no notable differences between test animal group and control group.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Positive response was not observed
There were no notable differences between test animal group and control group.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
only vehicle
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Positive response was not observed
There were no notable differences between test animal group and control group.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
only vehicle
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Positive response was not observed
There were no notable differences between test animal group and control group.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
only vehicle
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Positive response was not observed
There were no notable differences between test animal group and control group.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
only vehicle
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Positive response was not observed
There were no notable differences between test animal group and control group.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Challenge with test item evoked no positive responses in the test animals sensitized previously. At the same time, none of the animals proved to be positive in the control group. The net response value represented an incidence rate of 0% and the net score value of 0.00. According to the net percentage value of positivelye responded animals and to the net score calue of the skin reactions, the test item Cianacido was classified as a non-sensitiser.