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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Concerning Date of Draft Report planned 15/06/2008 and was made 18/06/2008; concerning vehicle was a miswritten in the nº lot.
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-Propenoic acid, 2-cyano-3-(3,4-dimethoxyphenyl)-, (2E)-
EC Number:
609-453-4
Cas Number:
37630-52-7
Molecular formula:
C12H11NO4
IUPAC Name:
2-Propenoic acid, 2-cyano-3-(3,4-dimethoxyphenyl)-, (2E)-
Test material form:
solid
Remarks:
powder
Specific details on test material used for the study:
Lot Nº 4/07

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:
50%
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:
50%
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:
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.
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.

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.