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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

A study according to OECD Guideline 406 was conducted with a structural analogue substance. The substance did not show skin sensitising properties in the Guinea Pig Maximization Test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 406. See chapter 13 report for a more detailed justification.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5 g/L test item
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2.5 g/L test item
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5 g/L test item
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
2.5 g/L test item
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 g/L Hexylcinnamaldehyde
No. with + reactions:
2
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
10 g/L Hexylcinnamaldehyde
No. with + reactions:
5
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Interpretation of results:
GHS criteria not met
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the provided information the test is not classified for skin sensitization according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.