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EC number: 946-565-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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:
- The rationale to read across the data is included in Section 13.
- Reason / purpose for cross-reference:
- 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:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- 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 chemical
- 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
- 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.
Reference
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.
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, the following aspects are considered to be crucial:
• For two analogues (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 target substance.
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 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.
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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