Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The skin sensitisation classification of the target substance ADP (CAS 70285-70-0) is currently not harmonised according to the CLP Regulation (EC) 1272/2008. Consequently, based on read-across (analogue approach, see attachment "ADP_70285-70-0_Readacross_Justification” in Section 13) and the results from the source substances ATP, DI-Na (CAS 987-65-5) and AMP (CAS 61-19-8), it can be assumed that also the target substance ADP (CAS 70285-70-0) can be considered as non-sensitising to the skin (CLP not classified).


 


ATP, DI-Na (CAS 987-65-5)


For this endpoint three studies were considered:


QSAR DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item. ATP, DI-Na (CAS 987-65-5) is predicted to be not sensitizing to the skin.


A valid DPRA assay was performed according to OECD 442C and GLP principles. Peptide depletion was calculated as 0.9% and 8.6% in Lysine and Cysteine Assays, respectively, resulting in a mean peptide depletion of 4.75%. This value places ATP, DI-Na (CAS 987-65-5) in the Minimal Reactivity Classification resulting in a DPRA prediction of Non-Sensitiser.


A valid Keratinosens assay was performed according to OECD 442D and GLP principles. The test item ATP, DI-Na (CAS 987-65-5) showed no toxicity (no IC30 and IC50 value). A biologically relevant, dose-related induction of the luciferase activity (EC1.5 values of 45.3 and 41.0µM in experiment 1 and 2, respectively) was measured in both experiments. The maximum luciferase activity induction (Imax) was 7.53-fold and 6.18-fold in experiment 1 and 2, respectively. ATP, Di-Na is therefore classified as positive in the KeratinoSens assay since positive results (>1.5-fold induction) were observed at test concentrations of =1000 µM with a cell viability of >70% compared to the vehicle control. However, ATP, Di-Na is considered to give false positive results in cell assays (such as the Keratinosense assay acc. to OECD 442D) because ATP is involved in cell proliferation and differentiation via the P2 receptor, which is present in most mammalian cells. Therefore, this result is considered a false positive.


In conclusion, ATP, DI-Na (CAS 987-65-5) is considered to be not sensitizing to the skin according to the results from QSAR DEREK and the DPRA assay (OECD 442C). Therefore, based on the results from non-cellular assays (namely from QSAR DEREK and the DPRA assay (OECD 442C)), ATP does not need to be classified for skin sensitization according to the CLP Regulation 1272/2008 and amendments.


 


AMP (CAS 61-19-8)


For this endpoint three studies were considered:


QSAR DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item. Adenosine-5’-monophosphate (AMP) (CAS 61-19-8) is predicted to be not sensitizing to the skin.


A valid DPRA assay was performed according to OECD 442C and GLP principles. Peptide depletion was calculated as 0.0% and 1.3% in Cysteine and Lysine Assays, respectively, resulting in a mean peptide depletion of 0.65%. This value places AMP (CAS 61-19-8) in the Minimal Reactivity Classification resulting in a DPRA prediction of non-sensitiser.


A valid Keratinosens assay was performed according to OECD 442D and GLP principles. The test item showed slight toxicity in experiment 1 (IC30 value of 1441 µM and no IC50 value) and no toxicity in experiment 2. A biologically relevant, dose-related induction of the luciferase activity (EC1.5 values of 22.8 and 25.8µM in experiment 1 and 2, respectively) was measured in both experiments. The maximum luciferase activity induction (Imax) was 21.9-fold and 13.6-fold in experiment 1 and 2, respectively. AMP is classified as positive in the KeratinoSens assay since positive results (>1.5-fold induction) were observed at test concentrations of <1000 µM with a cell viability of >70% compared to the vehicle control. However, AMP is considered to give false positive results in cell assays (such as the Keratinosense assay acc. to OECD 442D), because interconversion of AMP to ATP could be expected as result of normal metabolic activity of the cells during the experiment, and because ATP is involved in cell proliferation and differentiation via the P2 receptor, which is present in most mammalian cells. Therefore, this result is considered a false positive.


In conclusion, AMP (CAS 61-19-8) is considered to be not sensitising to the skin according to the results from QSAR DEREK and the DPRA assay (OECD 442C). Therefore, based on the results from non-cellular assays (namely from QSAR DEREK and the DPRA assay (OECD 442C)), AMP does not need to be classified for sensitization according to the CLP Regulation 1272/2008 and amendments.


 


 


 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Parameter:
other: alerts for skin sensitization
Remarks on result:
other: DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item. ATP, Di-Na is predicted to be not sensitizing to the skin.
Interpretation of results:
other: Non-Sensitizer
Conclusions:
DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item. ATP, Di-Na (CAS Nr. 987-65-5) is predicted to be not sensitizing to the skin.
Based on the readacross, it can be assumed that also the target substance ADP (CAS 70285-70-0) is predicted as not sensitizing to the skin.
Endpoint:
skin sensitisation: in vitro
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Run / experiment:
other: 1
Parameter:
Imax [442D]
Remarks:
maximal average fold induction of luciferase activity (Imax)
Value:
7.53
Positive controls validity:
valid
Remarks:
Imax: 2.69
Remarks on result:
other: maximal average fold induction of luciferase activity (Imax):7.53 fold
Key result
Run / experiment:
other: 2
Parameter:
Imax [442D]
Value:
6.18
Positive controls validity:
valid
Remarks:
Imax: 4.23
Remarks on result:
other: maximal average fold induction of luciferase activity (Imax): 6.18 fold
Key result
Run / experiment:
other: 1
Parameter:
EC 1.5 [442D]
Value:
45.3 µM
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks:
EC1.5: 13.7 µM
Key result
Run / experiment:
other: 2
Parameter:
EC 1.5 [442D]
Value:
41 µM
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks:
EC1.5 46.0 µM
Interpretation of results:
other: activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes
Conclusions:
In conclusion, ATP, Di-Na (CAS No 987-65-5) is classified as positive (activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes) under the experimental conditions described in this report.
Based on readacross, also the target substance ADP (CAS 70285-70-0) is predicted to be classified as positive (activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes).
Endpoint:
skin sensitisation: in chemico
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Run / experiment:
mean
Parameter:
other: Mean depletion value
Value:
4.75 %
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks:
Cinnamic aldehyde
Remarks on result:
other: Minimal reactivity (non sensitizer)
Remarks:
Minimal reactivity (non Sensitizer)
Interpretation of results:
other: minimally reactive: non-sensitizer
Conclusions:
In conclusion, according to the DPRA cysteine and lysine prediction model, ATP, Di-Na (CAS 987-65-5) was classified as minimally reactive and was, therefore, a non-sensitiser.
Based on readacross, also the target substance ADP (CAS 70285-70-0) is predicted as minimally reactive and, therefore, as non-sensitiser.
Endpoint:
skin sensitisation: in vitro
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Run / experiment:
other: 1
Parameter:
Imax [442D]
Value:
21.9
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks:
Imax: 3.40
Remarks on result:
other: Imax: 21.9
Key result
Run / experiment:
other: 2
Parameter:
Imax [442D]
Value:
13.64
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks:
Imax: 13.62
Remarks on result:
other: Imax: 13.64
Key result
Run / experiment:
other: 1
Parameter:
EC 1.5 [442D]
Value:
22.8 µM
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks:
EC1.5: 24.4 µM
Key result
Run / experiment:
other: 2
Parameter:
EC 1.5 [442D]
Value:
25.8 µM
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks:
EC1.5 15.8 µM
Interpretation of results:
other: activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes
Conclusions:
In conclusion, the KeratinoSensTM assay is valid and Adenosine-5’-monophosphate (AMP) (CAS no 61-19-8) is classified as positive (activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes) under the experimental conditions used in this study.
Based on readacross, also the target substance ADP (CAS 70285-70-0) is predicted to be classified as positive (activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes).
Endpoint:
skin sensitisation: in chemico
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Run / experiment:
mean
Parameter:
other: Mean depletion value
Value:
0.65 %
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks:
Cinnamic aldehyde
Remarks on result:
other:
Remarks:
Minimal reactivity (Non-sensitizer)
Interpretation of results:
other: minimally reactive: non-sensitizer
Conclusions:
In conclusion, according to the DPRA cysteine and lysine prediction model, AMP (CAS no. 61-19-8) was classified as minimally reactive and was, therefore, a non-sensitiser.
Based on readacross, also the target substance ADP (CAS 70285-70-0) is predicted as minimally reactive and, therefore, as non-sensitiser.
Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Parameter:
other: alerts for skin sensitization
Remarks on result:
other: DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item. Adenosine 5’-monophosphate (AMP) is predicted to be not sensitizing to the skin.
Interpretation of results:
other: Non-Sensitizer
Conclusions:
DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item. Adenosine-5’-monophosphate (AMP) (CAS Nr. 61-19-8) is predicted to be not sensitizing to the skin.
Based on readacross, it can be assumed that also the target substance ADP (CAS 70285-70-0) is predicted as not sensitizing to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification