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EC number: 215-355-9 | CAS number: 1323-42-8
- 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
Endpoint summary
Administrative data
Description of key information
The weight of evidence is that the substance is not a dermal sensitiser, despite some conflicting data.
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:
- weight of evidence
- Study period:
- Between 1994 and1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- guinea pig maximization test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Conducted prior to 1999
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 50% Freund's Complete Adjuvant (FCA)
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 2.5% hydroxystearic acid (HSA) in corn oil on day 1; on day 8, 10% HSA in corn oil
- Day(s)/duration:
- Days 1 and 8
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 2.5% HCA in 50% FCA/0.9% saline (50/50 test group) OR 50% corn oil in FCA/0.9% saline (50/50 control group)
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10% Sodium lauryl sulfate (SDS)
- Day(s)/duration:
- Day 7
- Adequacy of induction:
- not specified
- No. of animals per dose:
- 10 males, 10 females
- Details on study design:
- Intradermal and epicutaneous exposure.
The intradermal injections were administered (interscapular) on day 1 to five groups of animals: 50% Freund’s complete adjuvant (FCA) in 0.9% saline; 2.5% hydroxystearic acid in corn oil or vehicle alone; or 2.5% hydroxystearic acid in FCA/0.9% saline (50/50, v/v; test group); and the test material in FCA/0.9% saline or vehicle control (corn oil) in FCA.
One week after the initial intradermal injections, 10% sodium lauryl sulfate (SLS), 0.5 ml, was applied to the induction site. The next day (day 8), occlusive patches with the dermal dose (10% 12-HSA in corn oil) were applied to the test animals for 48 h; controls received patches with vehicle only. A rest period of 14 days occurred. On day 22, all animals received a 24-h occlusive challenge patch (2.5% hydroxystearic acid in corn oil). Control patches were placed on the left flank, and test material patches on the right flank. Sites were evaluated after 24, 48 and 72 h. - Challenge controls:
- vehicle (corn oil)
- Positive control substance(s):
- not specified
- Positive control results:
- Positive findings in both vehicle control (corn oil) animals and in test material animals in experiment 1. Results of the second experiment are summarized below.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- discrete erythma
- Remarks on result:
- other: indication of irritation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% in corn oil
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema
- Remarks on result:
- other: indication of irritation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% in corn oil
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema
- Remarks on result:
- not determinable because of methodological limitations
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema
- Remarks on result:
- other: suggestion of irritation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% in corn oil
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema
- Remarks on result:
- not determinable because of methodological limitations
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema
- Remarks on result:
- other: indication of irritation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% in corn oil
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- discrete eythema
- Remarks on result:
- not determinable because of methodological limitations
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other:
- Dose level:
- All doses
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 or 5% in acetone
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 or 5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea pig maximization test using 2.5% (intradermal) and 10% (epicutaneous) 12-hydroxystearic acid as induction dose and either 2.5%, 1.0% or 0.5% as elicitation dose, the substance did not result in an increase in the number of animals showing erythema, compared to corn oil or acetone vehicle controls. 12-Hydroxysteaic acid was evaluated as not inducing delayed contact hypersensitivity reactions, under the conditions of this study.
Reference
The first test used challenge doses too high, resulting in erythema in both controls and test animals.
The second test used lower patch challenge doses, these were difficult to interpret due to positive findings in the corn oil control animals. After the second challenge with the alternate vehicle (acetone), no cutaneous reactions were noted at any sites at the 24 h time point. At the 48 h time point, discrete erythema was reported at the vehicle patch site of 2 of 10 vehicle controls, and at 2/10 animals patched with the test material. There was no increase in the occurrence of positives between the control and test patches.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
While there is no known data specifically on the sensitisation potential of glyceryl monohydroxystearate (GMHS), there is a large body of knowledge of structurally related ricinoleates, stearates and castor oil derivatives. Another analogue, 12 -HSA, was tested in two types of studies as reviewed by the U.S. CIR Expert Panel: a LLNA (found to be positive) and two guinea pig maximisation tests, which were negative. The acid functional group may have impacted the outcome of the sensitisation studies; 12 -HSA is known to be irritating, and acids can result in the breaching of the skin barrier. Furthermore, glyceryl monoesters can be dermal penetration enhancers, allowing other concurrently applied materials or impurities to preferentially enter the dermal tissue (CIR, 2015). Preclinical studies (animal) and clinical studies (human volunteers) on a large category of glycerides (Monoglyceryl Monoesters, including Glyceryl Hydroxystearate (CIR, 2015) were the basis on which the Expert Panel concluded that category members were safe for use in cosmetics. Some of the positive animal outcomes reviewed in the CIR assessment may be explained by the presence of rosin derivatives or an unsaturated fatty acid functional group, which has been noted to cause potential "false positive" results in the LLNA assay, compared with outcomes in guinea pig assays (Kreiling et al., Food Chem Toxicol 46:1896 -1904, 2008, and Yamashita K et al., J. Toxicol Sciences 40(6):843 -853, 2015). Monoglycerides including glyceryl stearate, and triglycerides such as castor oil, were reviewed as part of a large category of Glycerides, (OECD HPV Programme, 2014), and the SIAR panel concluded that the untested members of the category were not expected to not be sensitisers. While there are a few case reports in humans of allergic response to castor oil derivatives, the Expert committee of the CIR, concerned with intentional dermal exposure to castor oil derivatives, concluded that the substances are safe for use in cosmetic products.
The weight of evidence is that glyceryl monohydroxystearate is not a dermal sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There are no known experimental or clinical data on the dermal sensitisation of glyceryl monohydroxystearate. Therefore, an analogue approach is used to evaluate this hazard for this endpoint, using 12 -hydroxystearic acid (12 -HSA), hydrogenated castor oil and castor oil, each of which possess additional functional groups not found in the registered substance and therefore represent worst case scenarios. Two of three of these compounds have relevant experimental or clinical data which shows them to be non-sensitisers, while 12 -HSA also has a positive LLNA. The acid functional group, known to break down the skin barrier, can help explain the LLNA findings. The castor oils have an unsaturated bond in the alkyl chain, and testing on these compounds may lead to "false positives" in the LLNA. Therefore, larger categories of glycerides (CIR 2015 and OECD 2014) can be consulted, where the findings of sensitisation studies result in the conclusion that long chain fatty glycerides are not dermal sensitisers. The long history of safe use of castor oil and hydrogenated castor oil in cosmetic products suggests that glyceryl monohydroxystearic is not a sensitiser. There is insufficient experimental data to meet the classification criteria for sensitisation according to Regulation EC No. 1272/2008. The substance is not classified.
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