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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

The test item may be classified as not a skin sensitizer using the LuSens test method but predicted as a sensitiser in the human Cell Line Activation Test (h-CLAT). The test results need to be considered in an overall weight of evidence assessment, i.e. as part of an integrated approach to testing and assessment (IATA). In order to have two out of three in vitro results DPRA would need to be conducted. However, the current DPRA prediction model cannot be used for complex mixtures of unknown composition or for substances of unknown or variable composition, complex reaction products or biological materials (i.e. UVCB substances) due to the defined molar ratio of test chemical and peptide. For this reason, read-across by grouping and read-across by analogue approach were used as part of the weight of evidence instead. The conclusion is that the substance is not predicted to be a skin sensitizer.

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:
weight of evidence
Justification for type of information:
See attached justification
Reason / purpose for cross-reference:
read-across source
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
positive control group not used - not necessary in human patch testing
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Remarks:
negative control group not used - not required for human patch testing
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3 x week 9 aplications (10% as supplied) 0.5ml path
No. with + reactions:
1
Total no. in group:
6
Clinical observations:
barely perceptible or spotty erithema
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not a skin sensitizer.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: HRIPT(Human Repeat Insult Patch Testing)
Deviations:
not specified
Principles of method if other than guideline:
Use repetitive epidermal contact to determine the potential of the title compound to induce primary or cumulative irritation and/or allergic contact sensitization.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
There is a weight of evidence from human patch testing so the need for animal testing was not deemed necessary.
Species:
human
Sex:
male/female
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml of the test material (SugaNate 160)
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml of the test material (SugaNate 160)
No. of animals per dose:
6
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3 x week 9 aplications (10% SugaNate) 0.5ml path
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3 x week 9 aplications (10% SugaNate) 0.5ml path
No. with + reactions:
1
Total no. in group:
6
Clinical observations:
barely perceptible or spotty erithema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3 x week 9 aplications (10% SugaNate) 0.5ml path. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: barely perceptible or spotty erithema.
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Remarks:
negative control group not used - not required for human patch testing
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
positive control group not used - not necessary in human patch testing
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, test material Suga®Nate 160, lot # 19518D08, did not indicate a potential for dermal irritation or allergic contact sensitization.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
The current DPRA prediction model cannot be used for complex mixtures of unknown composition or for substances of unknown or variable composition, complex reaction products or biological materials (i.e. UVCB substances) due to the defined molar ratio of test chemical and peptide. The QSAR Toolbox standardized workflow Skin Sensitization from GMPT Assay was used instead as part of the weight of evidence. Workflow principle attached.
Qualifier:
according to guideline
Guideline:
other: ECHA Guidance R.6
GLP compliance:
no
Remarks:
not applicable
Specific details on test material used for the study:
[Na+].[Na+].CCCCCCCCCCCCOC1OC(COCC(O)COC(=O)CC(O)(CC([O-])=O)C([O-])=O)C(O)C(O)C1O
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The test chemical was predicted to be a non-sensitizer to skin based on a QSAR Toolbox Standard Workflow prediction.
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
22 February 2022 - 12 April 2022
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 442E (In Vitro Skin Sensitisation assays addressing the key event on activation of dendritic cells on the Adverse Outcome Pathway for skin sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
human Cell Line Activation Test (h-CLAT)
Details of test system:
THP-1 cell line [442E]
Vehicle / solvent control:
cell culture medium
Negative control:
DL-Lactic acid
Positive control:
dinitrochlorobenzene (DNCB) [442E]
Key result
Group:
test chemical
Run / experiment:
run/experiment 2
Parameter:
other: RFI CD54
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: The RFI of CD54 was ≥ 200 % in the two highest test item concentrations (320.09 μg/mL and 384.11 μg/mL). EC200: 306.49 μg/mL
Key result
Group:
test chemical
Run / experiment:
run/experiment 1
Parameter:
other: RFI CD54
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: The RFI of CD54 was 200 % in the highest test item concentration of 384.11 μg/mL. EC200: 320.59 μg/mL
Key result
Group:
test chemical
Run / experiment:
run/experiment 2
Parameter:
other: RFI CD86
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: RFI was lower than 150 % at all tested doses
Key result
Group:
test chemical
Run / experiment:
run/experiment 1
Parameter:
other: RFI CD86
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: RFI was lower than 150 % at all tested doses
Outcome of the prediction model:
positive [in vitro/in chemico]
Interpretation of results:
other: Test result is considered in an overall weight of evidence assessment, i.e. as part of an integrated approach to testing and assessment (IATA) in accordance with OECD guideline 442E
Conclusions:
Under the conditions of the test, it can be concluded, that the test substance is predicted a sensitiser in the human Cell Line Activation Test (h-CLAT). The result does not allow for the non-classification or classification as skin sensitiser of the test substance and therefore further evaluation and/or data generation was performed.
Executive summary:

Two valid runs with a treatment period of 24 hours were performed.
In the experiment, the highest nominal applied concentration (384.11 μg/mL) was chosen based on the results obtained in the pre-test. A geometric series (factor 1.2) of 7 dilutions thereof was prepared and tested. Precipitation of the test item was not visible in any of the runs.
As solvent control for the test item, RPMI 1640 was used in a final concentration of 1 % in culture medium.
As positive control, 2,4-dinitrochlorobenzene (DNCB, CAS n. 97-00-7, ≥ 99% purity) was used.


In both runs the RFI of CD86 was not ≥ 150 % at any tested concentration with cell viability ≥ 50 %.
In run I: The RFI of CD54 was 200 % in the highest test item concentration of 384.11 μg/mL. EC200: 320.59 μg/mL
In run II: The RFI of CD54 was ≥ 200 % in the two highest test item concentrations (320.09 μg/mL and 384.11 μg/mL). EC200: 306.49 μg/mL


In conclusion, it can be stated that under the experimental conditions of this study, the test item was positive in the h-CLAT and is therefore considered to have the potential to activate dendritic cells and therefore to up-regulate the cell surface marker expression of THP-1 cells.

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
01 February 2022 - 28 April 2022
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
ARE-Nrf2 luciferase LuSens test method
Details of test system:
Lusens transgenic cell line [442D]
Vehicle / solvent control:
cell culture medium
Negative control:
DL-Lactic acid
Positive control:
other: p-Phenylenediamine
Key result
Group:
test chemical
Run / experiment:
other: run/experiment 4
Parameter:
Imax [442D]
Value:
1.2
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Run / experiment:
run/experiment 2
Parameter:
Imax [442D]
Value:
1.4
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Outcome of the prediction model:
negative [in vitro/in chemico]

In the experiment (repetition II and IV), the highest nominal applied concentration (45.0 μg/mL in repetition II and 64.8 μg/mL in repetition IV) was chosen based on the results obtained in the CRFT and repetition II. A geometric series (factor 1.2) of eleven dilutions thereof was prepared. Precipitation of the test item was not visible in any of the repetitions.
DMEM (final concentration: 1 %) was used as solvent control and medium no. 3 as growth control. Lactic acid (5000 μM) was used as negative control and p-Phenylenediamine (60 μM) as positive control.


No substantial and reproducible dose-dependent increase in luciferase induction equal or above 1.5 fold was observed in both valid repetitions up to the maximal tested concentration of the test item.

Interpretation of results:
other: Test result is considered in an overall weight of evidence assessment, i.e. as part of an integrated approach to testing and assessment (IATA) in accordance with OECD guideline 442D.
Conclusions:
Under the experimental conditions the test item may be classified as not a skin sensitizer using the LuSens test method.
Executive summary:

In the experiment (repetition II and IV), the highest nominal applied concentration (45.0 μg/mL in repetition II and 64.8 μg/mL in repetition IV) was chosen based on the results obtained in the CRFT and repetition II. A geometric series (factor 1.2) of eleven dilutions thereof was prepared. Precipitation of the test item was not visible in any of the repetitions.
DMEM (final concentration: 1 %) was used as solvent control and medium no. 3 as growth control. Lactic acid (5000 μM) was used as negative control and p-Phenylenediamine (60 μM) as positive control.


No substantial and reproducible dose-dependent increase in luciferase induction equal or above 1.5 fold was observed in both valid repetitions up to the maximal tested concentration of the test item.


Under the experimental conditions of this study, the test item, Suga®Citrate L1C, was negative in the LuSens assay and is therefore considered not to have the potential to activate the Nrf2 transcription factor.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification