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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08/02/2018 - 26/06/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes
Type of study:
direct peptide reactivity assay (DPRA)
Justification for non-LLNA method:
non animal method preferred
Details on the study design:
synthetic peptides containing cysteine or lysine were reacted with the test articles for 24hrs. After the incubation period, the extent of peptide depletion was analyzed using High Performance Liquid Chromatography (HPLC) coupled with UV spectrometric detection.
Positive control results:
cinnamic aldehyde:
mean peptide depletion (cysteine): 70.76
mean peptide depletion (lysine): 58.85
Parameter:
other: mean peptide depletion of cysteine and lysine
Value:
0.45
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Remarks:
minimal reactivity
Interpretation of results:
GHS criteria not met
Conclusions:
according to DPRA test performed on diheptyl succinate, substance is not a skin sensitizer.
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/02/2018 - 06/07/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: h-CLAT Human Cell Line Activation Test
Deviations:
yes
Remarks:
top concentration prepared in DMSO was biphasic
GLP compliance:
yes
Type of study:
activation of dendritic cells
Justification for non-LLNA method:
non animal method preferred
Details on the study design:
h-CLAT was used to assess the skin sensitization potential of test articles by monitoring the upregulation of cell surface markers CD54 and CD86, on the surface of human acute monocytic leukemia cells (THP-1) The upregulation of CD54 and CD86 in response to a skin sensitizer is correlated to dentritic cell activation, which is the third key initiating event of the skin sensitization pathway.
Positive control results:
2,4-dinitrochlorobenzene passes test for the 3 definitve assays.
Parameter:
other: EC200
Value:
1 000
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation
Parameter:
other: EC150
Value:
1 000
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation
Other effects / acceptance of results:
Due to a lack of solubility of the test article in the assay, no firm conclusion can be made from a negative response
Interpretation of results:
GHS criteria not met
Conclusions:
h-CLAT performed on dihetpyl succinate concludes substance is not a skin sensitizer. Due to the lack of solubility of the test article in the assay, no firm conclusion can be made from a negative response
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification