Registration Dossier

Administrative data

Description of key information

Based on a LLNA (OECD 429) the test item is considered to be a skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA:J
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0%, 5%, 10%, 25%
No. of animals per dose:
5
Details on study design:
Three groups of five animals were treated with one test substance concentration per group. The
highest test substance concentration was selected from the pre-screen test.
One group of five animals was treated with vehicle.
Key result
Parameter:
SI
Value:
1
Test group / Remarks:
0 %
Key result
Parameter:
SI
Value:
2.5
Test group / Remarks:
25 %
Key result
Parameter:
SI
Value:
4.2
Test group / Remarks:
50 %
Key result
Parameter:
SI
Value:
4.6
Test group / Remarks:
100 %
Key result
Parameter:
SI
Value:
>= 3
Test group / Remarks:
Overall
Parameter:
EC3
Value:
32.4
Test group / Remarks:
Overall
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The test item is considered to be a skin sensitizer.
Executive summary:

These results indicate that the test substance could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 32.4% was calculated.

The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at WIL Research Europe is an appropriate model for testing for contact hypersensitivity.

Based on these results:

- according to the recommendations made in the test guidelines (including all amendments), the test item would be regarded as skin sensitizer.

- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments), the test otem should be classified as skin sensitizer (Category 1B).

- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments), the test item should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

These results indicate that the test substance could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 32.4% was calculated.

The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at WIL Research Europe is an appropriate model for testing for contact hypersensitivity.

Based on these results:

- according to the recommendations made in the test guidelines (including all amendments), the test item would be regarded as skin sensitizer.

- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments), the test otem should be classified as skin sensitizer (Category 1B).

- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments), the test item should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776. As a result the substance is considered to be classified for skin sensitisation (Cat. 1B, H317).