Registration Dossier

Administrative data

Description of key information

The endpoint is based on a weight-of-evidence:

DEREK assesment of the constituents of the registered substance do not indicate sensitising potential. Furthermore, experimental data with two analogues show that these chemicals do not have sensitising properties.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation
Remarks:
other: QSAR
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
September - October 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The objective of this study was to obtain predictions on the skin sensitisation of the 4 representative potential C12-alkyl derivatives present in the substance with the DEREK NEXUS programme.
Justification for type of information:
QSAR prediction
Principles of method if other than guideline:
The objective of this study was to obtain predictions on the skin sensitisation of the 4 representative potential C12-alkyl derivatives present in the substance with the DEREK NEXUS programme. In this assessment version 2.0.0 of DEREK NEXUS was used. DEREK NEXUS is a knowledge-based system that contains over 700 toxicity alerts based on the presence of substructures. The system contains more than 50 alerts specific to skin sensitization. The rules are based on the presence of specific substructures, or chemical classes related to potential mechanisms for skin sensitization.
GLP compliance:
no

For all 4 representative potential C12-alkyl derivatives present in the substance, DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential.

Interpretation of results:
other: DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential for all 4 representative potential C12-alkyl derivatives present in the substance
Remarks:
Criteria used for interpretation of results: other: DEREK assessments
Conclusions:
The objective of this study was to obtain predictions on the skin sensitisation of 4 representative potential C12-alkyl derivatives present in the substance (monoamphoacetate A and B, and diamphoacetate A and B) with the DEREK NEXUS programme. In this assessment version 2.0.0 of DEREK NEXUS was used. DEREK NEXUS is a knowledge-based system that contains over 700 toxicity alerts based on the presence of substructures. The system contains more than 50 alerts specific to skin sensitization. The rules are based on the presence of specific substructures, or chemical classes related to potential mechanisms for skin sensitization. For all 4 representative potential C12-alkyl derivatives present in the substance, DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential.
Endpoint:
skin sensitisation
Remarks:
other: QSAR
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
October 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The objective of this study was to obtain predictions on the skin sensitisation of potential minor constituents (by-products) present in the substance with the DEREK NEXUS programme.
Justification for type of information:
QSAR prediction
Principles of method if other than guideline:
The objective of this study was to obtain predictions on the skin sensitisation of potential minor constituents (by-products) present in the substance with the DEREK NEXUS programme. In this assessment version 2.0.0 of DEREK NEXUS was used. DEREK NEXUS is a knowledge-based system that contains over 700 toxicity alerts based on the presence of substructures. The system contains more than 50 alerts specific to skin sensitization. The rules are based on the presence of specific substructures, or chemical classes related to potential mechanisms for skin sensitization.
GLP compliance:
no

For all 3 investigated potential minor constituents (by-products) present in the substance, DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential.

Interpretation of results:
other: DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential for 3 potential minor constituents (by-products) present in the substance
Remarks:
Criteria used for interpretation of results: other: DEREK assessments
Conclusions:
The objective of this study was to obtain predictions on the skin sensitisation of 3 potential minor constituents (by-products) present in the substance with the DEREK NEXUS programme. In this assessment version 2.0.0 of DEREK NEXUS was used. DEREK NEXUS is a knowledge-based system that contains over 700 toxicity alerts based on the presence of substructures. The system contains more than 50 alerts specific to skin sensitization. The rules are based on the presence of specific substructures, or chemical classes related to potential mechanisms for skin sensitization. For all 3 investigated potential minor constituents (by-products) present in the substance, DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential.
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
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
1 % (solid content approx. 0.394%)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % (solid content approx. 0.394%). No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
1 % (solid content approx. 0.394%)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1 % (solid content approx. 0.394%). No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 % (solid content approx. 0.394%)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 % (solid content approx. 0.394%). No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1 % (solid content approx. 0.394%)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1 % (solid content approx. 0.394%). No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitisation potential of REWOTERIC AM C (amphoacetates C8-C18) has been investigated according to OECD 406 and GLP. In this adjuvant type guinea pig test method for skin sensitisation, positive reactions in 0 of the 20 animals (0%) were observed during challenge. Therefore, based on the results of this study the substance is not classified as a skin sensitiser in accordance with the CLP Regulation. This result is read-across to the registered substance.
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
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% (solid content approx. 7%)
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% (solid content approx. 7%). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No data.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
20% (solid content approx. 7%)
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 20% (solid content approx. 7%). No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: No data.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
20% (solid content approx. 7%)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20% (solid content approx. 7%). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
20% (solid content approx. 7%)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 20% (solid content approx. 7%). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitisation potential of DEHYTON W (amphoacetates C12) has been investigated similar to OECD 406 and GLP. In this adjuvant type guinea pig test method for skin sensitisation, positive reactions in 5 of the 20 animals (25%) were observed during challenge. Therefore, based on the results of this study the substance does not need to be classified as a skin sensitiser in accordance with the CLP Regulation. This reasult is read-across to the registered substance.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

DEREK assessments

Predictions on the skin sensitisation potential of the 4 representative potential C12-alkyl derivatives and of 3 potential minor constituents (by-products) present in the substance were obtained with the DEREK NEXUS programme. In this assessment version 2.0.0 of DEREK NEXUS was used. DEREK NEXUS is a knowledge-based system that contains over 700 toxicity alerts based on the presence of substructures. The system contains more than 50 alerts specific to skin sensitization. The rules are based on the presence of specific substructures, or chemical classes related to potential mechanisms for skin sensitization. For all 7 investigated structures (potentially) present in the substance, DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential.

Additional supporting considerations

The main potential surfactant structures present did not trigger any structural alerts in a second sensitization assessment model, ToxTree v.2.1.0, i.e. no alert for nucleophilic aromatic substitution, Schiff Base formation, Michael acceptor, acyl transfer agents, or nucleophilic aliphatic substitution. Despite a long history of use in consumer products, there are only rare occurrences of in-use sensitization reports with surfactants in general, and with alkylamphoacetates more specifically.

Read-Across from analogue amphoacetates C12 (GPMT)

In an adjuvant type guinea pig test method for skin sensitisation with analogue amphoacetates C12, conducted similar to OECD 406 and GLP, positive reactions in 5 of the 20 animals (25%) were observed during challenge. Although a deviation of the study was to base the choice for the intradermal induction exposure on the minimal irritating exposure instead of on the highest exposure to cause mild-to-moderate skin irritation, the concentrations selected for the other phases of the study (topic applications for the induction and challenge phases) were in compliance with the guidelines. Based on the results of this study the substance does not need to be classified for skin sensitising in accordance with the CLP Regulation. This result is read-across to this substance. The read-across from this analogue to the registered substance for the skin sensitising potential of the substance is considered scientifically justified based on the overall information available (see rationale attached in Section 13).

Read-Across from analogue amphoacetates C8 -C18 (GPMT)

In an adjuvant type guinea pig test method for skin sensitisation with another analogue (amphoacetates C8 -C18), conducted according to OECD 406 and GLP, positive reactions in 0 of the 20 animals (0%) were observed during challenge with an aqueous solution. The read-across from this analogue to the registered substance for the skin sensitising potential of the substance is considered scientifically justified based on the overall information available.

Conclusion

Based on a weight-of-evidence approach, taking into account all the available information of two analogues, it is considered justified to conclude that the substance has a low potential to cause skin sensitisation in humans.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on a weight-of-evidence approach, taking into account all the available information of analogues, the substance is not classified for skin sensitisation in accordance with the CLP Regulation.

Due to the lack of data, the substance is not classified for respiratory sensitisation. In addition, given the physical-chemical properties of the substance and its use pattern, a potential for causing respiratory sensitisation is unlikely.