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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
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EC number: - | 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
Carcinogenicity
Administrative data
Description of key information
Oral (similar to OECD 453, read across), rat: NOAEL ≥ 1970 mg/kg bw/day
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 970 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no treatment-related neoplastic findings up to and including the highest tested dose level of 1970 mg/kg bw/day.
- Key result
- Critical effects observed:
- no
- Conclusions:
- The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their repeated dose toxicity potential. The toxicity of the target substance is estimated based on an adequate and reliable combined chronic oral toxicity and carcinogenicity study with a structural analogue source substance. In a 2-year chronic feeding study (similar to OECD guideline 453) in male and female rats with the source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS) no treatment-related neoplastic findings were found, up to and including the highest tested dose level of 5% in diet, which corresponds to 1970 mg/kg bw/day for male rats and 2440 mg/kg bw/day for female rats. Therefore, a NOAEL for carcinogenicity of ≥ 1970 mg/kg bw was derived for the target substance Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 970 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- The available information comprises adequate and reliable (Klimisch score 2) studies from an analogue source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, eco-toxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex X, 8.9, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the read-across approach no carcinogenic potential is expected for Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS). Therefore, CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.
Additional information
Read across justification
There are no data on the repeated dose toxicity of Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS). The assessment was therefore based on a study conducted with an analogue substance as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Repeated dose toxicity/carcinogenicity, oral, chronic
A combined chronic oral toxicity (14 rats/sex/dose for 52 weeks) and carcinogenicity study (50 rats/sex/dose for 104 weeks) was performed in Fischer 344/Du Crj rats similar to OECD guideline 453. The rats were fed a diet containing the source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS) at 0, 1%, 3% or 5% in the diet, corresponding to 394, 1160, or 1970 mg/kg bw/day in males and 480, 1440 or 2440 mg/kg bw/day in females. Adequate observations, physical and ophthalmological examinations, body weight and food consumption recordings as well as haematological and clinical chemistry examinations were carried out throughout the study. Gross necropsy was performed on all animals at termination and organ weights were recorded for liver, kidneys, adrenals, testes, ovaries, brain, heart, lungs and spleen. Histopathological examinations were carried out on 48 tissues and organs in all control and high-dose animals and in animal tissues showing macroscopic changes in the low- and mid-dose groups. Based on the absence of treatment-related neoplastic effects, the NOAEL was found to be 5% in the diet, equivalent to 1970 mg/kg bw/day in males and 2440 mg/kg bw/day in females.
Based on the available data and following the analogue read across approach, no carcinogenic potential is expected for the target substance Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS).
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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