Registration Dossier

Administrative data

Description of key information

One skin sensitisation study in guinea pigs (maximization assay), conducted in accordance with OECD 406 and GLP (Klimisch reliability 1), showed that a substance analogue was not sensitising to skin. This result is read across to the registered substance, the rationale is attached in Section 13. DEREK NEXUS (version 5.0.2) did not find any substructures in its database that fired an alert for skin sensitisation potential for the chemical structures present in C8 Amphoacetates (this is considered relevant for the C8 and the C10 constituents).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In Section 13 of the IUCLID dossier, a report is attached in which the category approach is reported according to ECHA Guidance for the implementation of REACH, Guidance on information requirements and chemical safety assessment, Chapter R.6 (reporting format for a chemical category).
Reason / purpose:
read-across source
Positive control results:
Positive control data were provided by periodically tests (RCC project 902068) from 27-OCT-1997 to 04-DEC-1997.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Remarks:
Historical control data
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Remarks:
Historical control data

RESULTS:

SKIN EFFECTS AFTER INTRADERMAL INDUCTION -PERFORMED ON TEST DAY 1

- The expected and common findings were observed in the control and test group after intradermal application of FCA in physiological saline and with/without the test article; the intradermal applications were observed with erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation.

SKIN EFFECTS AFTER EPIDERMAL INDUCTION - PERFORMED ON TEST DAY 8

-CONTROL GROUP: No erythematous or oedematous reaction was observed in the animals treated with bi-distilled water only.

-TEST GROUP: Slight to well-defined erythematous reactions were observed in all test animals treated with the test article at 75 % in bi-distilled water.

SKIN EFFECTS AFTER THE CHALLENGE - PERFORMED ON TEST DAY 22

-CONTROL AND TEST GROUP: No skin reactions were observed in the animals either when treated with bi-distilled water only or when treated with the test article at 1 % in bi-distilled water.

VIABILITY / MORTALITY / MACROSCOPIC FINDINGS

- As there were no deaths during the course of the treatment period no necropsies were performed.

CLINICAL SIGNS, SYSTEMIC

- No symptoms of systemic toxicity were observed in the animals.

BODY WEIGHTS

- The body weight of the animals was within the range commonly recorded for animals of this strain and age.

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of a reliable GPMT study, REWOTERIC AM C was considered to be not sensitising. This result is read across to the registered substance.
Executive summary:

In a dermal sensitization study with the substance in water, young adult Himalayan spotted guinea pig (10 females) were tested using the MAXIMIZATION TEST method according to OECD Guideline 406 (April 29, 1993) and Directive 96/54/EEC, B.6. (July 30, 1996).

The lowest irritating concentration was chosen at the induction phase and the maximal non-irritating concentration was used at challenge.

None of the animals of the test group were observed with positive skin reactions after treatment with the maximum non-irritant concentration of the test article of 1 % in water. Based on these results, REWOTERIC AM C was considered to be not sensitising. This result is read across to the registered substance, details on the read across rationale are attached in section 13.

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

A guinea pig maximization test, which is the preferred test for surfactants, was performed according to OECD guideline 406 with REWOTERIC AM C, which is an Amphoacetate C8-C18 with 100% mono amphoacetates. The lowest irritating concentration was chosen at the induction phase and the maximal non-irritating concentration was used at challenge. After epidermal induction performed on test day 8, slight to well-defined erythematous reactions were observed in all test animals treated with the test article at 75 % in bi-distilled water. After challenge, none of the animals of the test group were observed with positive skin reactions after treatment with the maximum non-irritant concentration of the test article of 1 % in water. Based on these results, REWOTERIC AM C was considered to be not sensitising.

In order to substantiate the findings of the GPMT, predictions on the skin sensitizing potential of the 4 representative C12-alkyl derivatives (monoamphoacetate A and B, and diamphoacetate A and B) and 3 potential minor constituents (by-products) present in amphoacetate C8 were performed with the DEREK NEXUS program (v 5.0.2). DEREK NEXUS is a knowledge-based system that contains more than 80 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. The representative mono- and di-acetate structures with C8 amphoacetate were investigated with DEREK NEXUS (the report is attached in Section 13). For all of these structures DEREK NEXUS did not find any substructures in its database that fired an alert for sensitisation potential.

The conclusions of a safety assessment of Cocoamphoacetate was published. This substance was reported to be, at a concentration of 10%, neither irritant nor sensitizer in a repeated insult patch test on 141 subjects. Although these results were published in a peer-reviewed journal, which can be regarded to be scientific expert judgement, the data are not found reliable due to the fact that no information was given on the exact study outline, identity and purity of the test substance and that no results were included in the report.

In order to conclude on the skin sensitising potential of Amphoacetates C8 -C10 the following aspects are considered to be crucial:

           For two members of the category (Amphoacetates C8-18 and Amphoacetates C12), it has been shown that a guinea pig maximization study results in a negative outcome.

           DEREK NEXUS did not find any substructures in its database that fired an alert for skin sensitisation potential for the chemical structures present in the amphoacetates.

           In spite of wide spread use of the alkylamphoacetates, no reports on cases of skin sensitization in the public domain or in company-owned data can be found.

Based on this information, it is considered scientifically valid to read across the data on skin sensitization potential to the other members of the category.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data available. Any significant inhalation of the substance is unlikely as the substance is manufactured, marketed and used in aqueous solution only.

Justification for classification or non-classification

Based on the available data, C8 -C10 Amphoacetates is not classified for skin sensitising properties according to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.

Furthermore, the substance is not classified for respiratory sensitisation, due to lack of data.