Registration Dossier
Registration Dossier
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EC number: 274-533-4 | CAS number: 70285-70-0
Endpoint summary
Administrative data
Description of key information
Skin irritation / corrosion
The skin irritation/corrosion 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 the 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 to be non-irritant to skin and is therefore not classified according to the EU Regulation on classification, labeling and packaging (CLP) (EC) No 1272/2008.
ATP, DI-Na (CAS 987-65-5)
In the in vitro skin irritation test, using the EPISKIN model, the test item did not show significantly reduced cell viability in comparison to the negative control (mean value: 83 %) and therefore reveals no skin irritation potential under the utilised testing conditions. The test item ATP, Di-Na (CAS 987-65-5) is considered to be non-irritant to skin and is therefore not classified (CLP not classified).
AMP (CAS 61-19-8)
In the vitro skin irritation test, using the EPISKIN model, the test item did not show significantly reduced cell viability in comparison to the negative control (mean value: 105 %) and therefore reveals no skin irritation potential under the utilised testing conditions. The test item Adenosine-5’-monophosphate (AMP) (CAS No. 61-19-8) is considered to be non-irritant to skin and is therefore not classified (CLP not classified).
Eye irritation
The eye irritation/corrosion 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 the 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-irritant to eye (not classified).
ATP, DI-Na (CAS 987-65-5)
For this endpoint two in vitro studies were performed: The Bovine Corneal Opacity and Permeability (BCOP) assay (OECD guideline 437) and the three-dimensional RhCE tissue assay in the EpiOcular™ model (OECD 492). The mean IVIS Score for ATP, Di-Na (CAS 987-65-5) in the BCOP assay was 18.50, therefore no prediction on classification could be made for the test item using the BCOP. In the three-dimensional RhCE tissue assay in the EpiOcular™ model, the test item did not show significantly reduced cell viability in comparison to the negative control (mean viability: 77 %). The test item ATP, Di-Na (CAS No. 987-65-5) is therefore considered as non-irritant to eye (CLP not classified).
AMP (CAS 61-19-8)
For this endpoint two in vitro studies were performed: The Bovine Corneal Opacity and Permeability (BCOP) assay (OECD guideline 437) and the three-dimensional RhCE tissue assay in the EpiOcular™ model (OECD 492). The mean IVIS score for AMP (CAS 61-19-8) in the BCOP assay was 3.43, therefore no prediction on classification could be made for the test item using the BCOP. In the three-dimensional RhCE tissue in the EpiOcular™ model, the test item did not show significantly reduced cell viability in comparison to the negative control (mean viability: 88 %). The test item Adenosine-5’-monophosphate (AMP) (CAS No. 61-19-8) is therefore considered as non-irritant to eye (CLP not classified).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 83
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean viability value of three tissues
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin irritation potential under the utilised testing conditions. The test item ATP, Di-Na (CAS 987-65-5) is considered to be non-irritant to skin and is therefore not classified (UN GHS No Category / CLP not classified).
Based on the readacross, also the target substance ADP (CAS 70285-70-0) can be considered to be non-irritant to skin and is therefore not classified according to the EU Regulation on classification, labeling and packaging (CLP) (EC) No 1272/2008. - Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 105
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean viability value of three tissues
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin irritation potential under the utilised testing conditions. The test item Adenosine-5’-monophosphate (AMP) (CAS No. 61-19-8) is considered to be non-irritant to skin and is therefore not classified (UN GHS No Category / CLP not classified).
Based on the readacross, also the target substance ADP (CAS 70285-70-0) can be considered to be non-irritant to skin and is therefore not classified according to the EU Regulation on classification, labeling and packaging (CLP) (EC) No 1272/2008.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- 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
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Single experiment
- Value:
- 18.5
- Vehicle controls validity:
- valid
- Remarks:
- IVIS: 0.0
- Positive controls validity:
- valid
- Remarks:
- IVIS: 106.60
- Remarks on result:
- not determinable
- Remarks:
- No Prediction can be made
- Interpretation of results:
- GHS criteria not met
- Remarks:
- no prediction could be made
- Conclusions:
- In conclusion, no prediction could be made for ATP, Di-Na (CAS 987-65-5) using the BCOP assay according to the UN GHS classifications and the CLP classification system.
- Endpoint:
- eye irritation: in vitro / ex vivo
- 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
- Irritation parameter:
- other: Mean Tissue Viability (% of negative control)
- Value:
- 77
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained from this in vitro eye irritation test, using the EpiOcular™ model, indicated that the test item reveals no eye irritation potential under the applied testing conditions. According to the current OECD Guideline No. 492, ATP, Di-Na is (CAS No. 987-65-5), thus, considered as non-irritant to eye (UN GHS No Category).
Based on the readacross, it can be assumed that also the target substance ADP (CAS 70285-70-0) can be considered as non-irritant to eye (not classified). - Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- other: Mean Tissue Viability (% of negative control)
- Value:
- 88
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained from this in vitro eye irritation test, using the EpiOcular™ model, indicated that the test item reveals no eye irritation potential under the applied testing conditions. According to the current OECD Guideline No. 492, Adenosine-5’-monophosphate (AMP) (CAS No.: 61-19-8) is, thus, considered as non-irritant to eye (UN GHS No Category).
Based on readacross, it can be assumed that also the target substance ADP (CAS 70285-70-0) can be considered as non-irritant to eye (not classified). - Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Single experiment
- Value:
- 3.43
- Vehicle controls validity:
- valid
- Remarks:
- IVIS: 0.00
- Positive controls validity:
- valid
- Remarks:
- IVIS: 116.33
- Remarks on result:
- not determinable
- Remarks:
- No prediction can be made
- Interpretation of results:
- other: no prediction could be made
- Conclusions:
- In conclusion, using the BCOP assay (OECD 437 test method), ‘No prediction can be made’ for AMP (CAS No. 61-19-8) according to the UN GHS classifications and the CLP classification system.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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