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EC number: 266-930-6 | CAS number: 67701-06-8 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 04-005-00.
- 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
Irritation / corrosion:
- skin: not irritating (OECD 404, human data; Analogy CAS 57-10-3, CAS 57-11-4);
- eye: not irritating (OECD 405; Analogy CAS 143-07-7, CAS 57-10-3, CAS 57-11-4, CAS 90990-10-6);
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin
Due to the lack of reliable data with fatty acids C14-18 and C16-18-unsatd. on skin irritation, studies with two of the main constituents, C16 fatty acid (palmitic acid) and C18 fatty acid (stearic acid), are used for hazard assessment. Since fatty acids C14-18 and C16-18-unsatd., palmitic acid and stearic acid belong to the same category based on structural and toxicological properties, this approach can be regarded as scientifically justified. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).
Skin irritation by palmitic acid was evaluated in a study performed under GLP according to OECD guideline 404 with the exception, that the test was performed under occlusive condition (Kästner, 1988). Four Kleinrussen rabbits received an application of 0.5 g palmitic acid to the shaved skin under occlusion for 4 hours. The readings 24, 48, and 72 hours after application did not reveal any signs of irritation, thus resulting in mean scores of 0 for erythema and edema, respectively. As a consequence, test was cancelled due to welfare reasons. Based on the results, palmitic acid can be regarded as not irritating to skin.
In a study with human subjects, palmitic acid and 19 other substances were investigated with a closed epicutanous test. 10 µl of palmitic acid at a concentration of 50% was applied to the back of the volunteers for 24 hours using a Large Finn Chamber (Matthies, 1988). The reactions were scored for edema, erythema, scaling and fissures 1, 6, 24, 48, 72 and 144 hours after application. As result, for all readings the score 0 was found.
Skin irritation by stearic acid was evaluated in a study performed in accordance with federal guidelines (International Bio-Research, 1974). 0.5 mL of stearic acid was applied to the abraded skin of 6 New Zealand White rabbits under occlusion for 24 hours.at 24 and 72 hours after application revealed no signs of irritation. Although a longer application under occlusion than suggested according to actual guidelines, the resulting scores are 0, both for erythema and edema, respectively.
Due to the similar structural and toxicological properties of the members within the category including fatty acids C14-18 and C16-18-unsatd. and its main constituents palmitic acid and stearic acid, the same result is expected for fatty acids C14-18 and C16-18-unsat.. Thus, it is not irritating to skin.
Eyes
Due to the lack of reliable data with fatty acids C14-18 and C16-18-unsatd. on eye irritation, studies with three of the main constituents, C12 fatty acid (lauric acid), C16 fatty acid (palmitic acid) and C18 fatty acid (stearic acid) and a study with the analogue fatty acids C12-14 are used for hazard assessment. Since fatty acids C14-18 and C16-18-unsatd., lauric acid, palmitic acid and stearic acid belong to the same category based on structural and toxicological properties, this approach can be regarded as scientifically justified. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).
Eye irritation by lauric acid was evaluated in a study performed under GLP according to OECD guideline 405, where 52.45 +/- 0.45 mg of lauric acid was instilled into the eyes of 3 New Zealand White rabbits (Daamen, 1989). The result mean scores for corneal opacity, iris, and conjunctival erythema and chemosis after 24 – 72 h were 0.9, 0.8, 2.9 and 1.6, respectively. While the effect on the iris and the edema disappeared within 7 and 21 days, respectively, corneal opacity and erythema were still present at the end of the 21 day observation period. In addition, neovacularisation starting from day 7 until day 21 was found. Thus, lauric acid was found to be irritating to eyes in this study. Fatty acids C12-14 containing 73.6% lauric acid was found to be not irritating to eyes, when it was tested in a study performed according to GLP and OECD guideline 405 where 0.1 g was instilled into the eyes of three New Zealand White rabbits (Stelter, 2010). While neither mortality nor significant clinical signs of toxicity were observed until 21 days after the test item application, the resulting mean scores (24 – 48 – 72 hours) for corneal opacity, iris, conjunctival erythema and chemosis were 0, 0, 0.78, and 0.67, respectively. Thus, lauric acid at a concentration of 73.6% was not found to be irritation to eyes.
Eye irritation by palmitic acid was analyzed in a study performed in accordance with GLP and according to OECD guideline 405 (Kästner, 1988). 0.1 g of palmitic was instilled into the rtights eyes of four Kleinrussen rabbits while the untreated left eyes served as control. The reactions were examined 1, 6, 24, 48, and 72 hour after administration and resulted in mean scores of 0, 0, 0.3, 0 and 0 for corneal opacity, iris, conjunctival redness and chemosis, and exudation, respectively. Since all signs were subsided on day three after instillation, the study was cancelled on that day due to animal welfare reasons. Based on the findings, palmitic acid can be regarded as not irritating to eyes.
In a published study performed according to national guidelines, stearic acid was instilled into the eyes of six rabbits (Briggs et al., 1976). Mild conjunctival erythema was found in 2 animals at 24 and 48 hours while all signs of irritation hat subsided completely in 72 hours. Thus, a mean score of 0.2 for conjunctival erythema could be calculated. Based on the results, stearic acid can be regarded as not irritating to eyes
Due to the structural and functional similarities of members within the category including fatty acids C14-18 and C16-18-unsatd. and its main constituents palmitic acid and stearic acid and the analogue fatty acids C12-14, the same result is expected for fatty acids C14-18 and C16-18-unsat. Thus, fatty acids C14-18 and C16-18-unsatd. are not irritating to eyes based on the contents of the individual constituents and their non-irritating properties.
Justification for classification or non-classification
The substance may contain few of lauric acid (C12), which is classified as R41/eye damage Cat 1. The specific concentration limit for the lauric acid is established as 73.6% based on a reliable experimental data. According to DPD (1999/45/EC) or CLP (1272/2008/EC) classification criteria for irritation/corrosion, fatty acids C14-18 and C16-18-unsatd. do not fulfill the criteria for classification and thus a non-classification is warranted for this endpoint as the concentration of C12 is lower than 73.6%.
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