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EC number: 250-097-0 | CAS number: 30233-64-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- other: weight of evidence
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- Because of the structural and functional similarities, data from other glyceryl monoesters are included in this weight of evidence assessment as supporting data.
The following expert opinion (attached in section 13) will be used in the weight of evidence approach:
CIR 2016: Cosmetic Ingredient Review. Safety assessment of monoglyceryl monoesters as used in cosmetics. Final amended report, January 15, 2016.
CIR 2019: Safety Assessment of Fatty Acids & Fatty Acid Salts as Used in Cosmetics
EFSA 2017: Re-evaluation of glycerol (E 422) as a food additive
OECD SIDS 2001: Docosanoic acid. CAS No: 112-85-6. SIDS Initial Assessment Report for 13th SIAM
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
- Principles of method if other than guideline:
- In a 28 day repeated dose toxicity study glyceryl rosinate was administered via the diet at 30% in 70% corn oil, given at 0.2% and 1.0%. No effects on mortality morbidity, clinical signs, food consumption, or body weight gain; no gross or microscopic lesions were observed. The NOAEL was set at 1%.
In 28 days gavage study 10 male and 5 female Wistar rats (recovery group with an additional 5 males and females in the control and high dose group), glycerides, C8-18 and C18-unsatd mono- and di-, acetates was administered at 0, 100, 300 and 1000 mg/kg/day. No clinical signs of toxicity: no toxicological relevant changes in haematology, clinical chemistry, organ weights or gross or microscopic lesions. The NOAEL was set at 1000 mg/kg bw/day.
In an oral (gavage) OECD 422 study evaluating repeated dose toxicity as well as screening for reproduction and developmental toxicity, Docosanoic acid (behenic acid) did not shown any repeated dose toxicity. 13 male and 13 female Sprague-Dawley rats per dose group was given 0, 100, 300, or 1000 mg/kg bw/day in corn oil. Males were treated 42 days and females were treated for 14 days prior to mating to day 3 of lactation. The NOAEL was set to be > 1000 mg/kg bw/day as no treatment-related adverse effects were observed.
In support of the above conclusion, CIR concluded no concern for repeated dose toxicity in their evaluation of fatty of monoglyceryl monoesters (2016). The same CIR conclusion was drawn in relation to fatty acids and fatty acids salts (2019) where the NOAELs for Behenic Acid (up to 1000 mg/kg bw/day), Calcium Stearate (up to 2000 mg/kg bw/day), and Capric Acid (up to 1000 mg/kg bw/day) were greater than or equal to the highest doses tested in oral studies.
In their evaluation of glycerol, EFSA (2017) also concluded no concern for repeated dose toxicity. Overall conclusion was no safety concern regarding the use of glycerol (E 422) as a food additive.
- GLP compliance:
- not specified
- Remarks:
- Data from expert opinions
Test material
- Reference substance name:
- Docosanoic acid, monoester with glycerol
- EC Number:
- 250-097-0
- EC Name:
- Docosanoic acid, monoester with glycerol
- Cas Number:
- 30233-64-8
- Molecular formula:
- C25H50O4
- IUPAC Name:
- 2-hydroxy-1-(hydroxymethyl)ethyl docosanoate
- Test material form:
- solid
Constituent 1
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Remarks on result:
- other: Collection of relevant data, see attached file
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw (total dose)
Applicant's summary and conclusion
- Conclusions:
- Based on the available data used in a weight of evidence approach, it can be
concluded that glycerol monobehenate is of very low concern for repeated dose toxicity;
and it can with a high degree of confidence be concluded that an assumed NOAEL
is above 1000 mg/kg bw/day, which is normally considered as the highest relevant
dose level when testing for repeated dose toxicity. Thus, no STOT RE
classification according to (EC) No 1272/2008 is not warranted. - Executive summary:
Docosanoic acid, monoester with glycerol (glycerol monobehenate) is a mono constituent substance with a purity of 80-90%. Data on repeated dose toxicity of glycerol monobehenate was not available.
However, data from other glyceryl monoesters with structural and functional similarities are available and were included in this weight of evidence assessment. Data on Docosanoic acid (behenic acid) was also used as well as data on glycerol. No signs of toxicity were observed in two 28-day studies for glyceryl rosinate and glycerides, C8-18 and C18-unsatd. mono- and di-, acetates. The NOAEL for these two studies is therefore the highest dose tested which was 1000 mg/kg bw/day. This was also concluded for Docosanoic acid (behenic acid) in an OECD 422 study, the NOAEL was set to be > 1000 mg/kg bw/day as no treatment-related adverse effects were observed. For glycerol, EFSA also concluded no concern for repeated dose toxicity (EFSA, 2017) in their evaluation of glycerol. Overall, they concluded that there was no safety concern regarding the use of glycerol (E 422) as a food additive. Based on the available data used in a weight of evidence approach, it can be concluded that monobehenate is of very low concern for repeated dose toxicity; and it can with a high degree of confidence be concluded that an assumed NOAEL is above 1000 mg/kg bw/day, which is normally considered as the highest relevant dose level when testing for repeated dose toxicity. Thus, no STOT RE classification according to (EC) No 1272/2008 is not warranted.
The available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. The weight-of-evidence approach is justified based on common functional group and common
precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint
conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.
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