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EC number: 241-646-5 | CAS number: 17671-27-1
- 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
Skin sensitisation in vivo (OECD 406): not sensitising
Study performed with the analogue source substance fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7)
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:
- Refer to Analogue Justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of toxicity observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Source: EC 701-233-7, NOF, 2008, GPMT
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of toxicity observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Source: EC 701-233-7, NOF, 2008, GPMT
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Source: EC 701-233-7, NOF, 2008, GPMT
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Source: EC 701-233-7, NOF, 2008, GPMT
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 3% in PEG 300
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity observed
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- RCC Study B59455; Source: EC 701-233-7, NOF, 2008, GPMT
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 3% in PEG 300
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No signs of toxicity observed
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- RCC Study B59455; Source: EC 701-233-7, NOF, 2008, GPMT
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- A reliable study conducted in accordance with OECD guideline 406 and GLP found the test material to be non-sensitising to the skin of guinea pigs in a maximisation test based on Magnusson and Kligman. No signs of toxicity were evident in the guinea pigs of the control or test group and no deaths occurred.
- Executive summary:
The potential of the target substance docosyl docosanoate (CAS 17671-27-1) to induce skin sensitisation is estimated based on an adequate and reliable in vivo study with an analogue source substance. In this study the test substance did not induce skin sensitisation in guinea pigs as determined in a maximisation test according to Magnusson and Kligman. No signs of toxicity were evident in the guinea pigs of the control or test group and no deaths occurred. Therefore, the lack of a skin sensitisation potential is taken forward to the hazard assessment and the determination of the classification of the target substance. As explained in the Analogue Justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data on skin sensitisation are available for docosyl docosanoate (CAS 17671-27-1). An adequate and reliable study performed with an analogue source substance is, therefore, used to assess the endpoint skin sensitisation.
A Guinea Pig Maximisation Test was performed with fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7) in 15 female albino Dunkin Hartley guinea pigs under GLP conditions (NOF, 2008, GPMT). The study was conducted in accordance with OECD guideline 406 and under GLP conditions. The intradermal induction of sensitisation was performed in the nuchal (flank) region with a 1% dilution of the test substance in polyethylene glycol (PEG 300) and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline on Day 1. The epidermal induction was conducted for 48 h under occlusion with a 50% solution of the test substance in PEG 300 one week after the intradermal induction (Day 8) and following pre-treatment of the test areas with 10% sodium lauryl sulfate (SLS) approximately 24 h prior to application of the test substance. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally with PEG 300 under occlusion following pre-treatment with 10% SLS. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 50% in PEG 300 and PEG 300 alone, under an occlusive dressing. Cutaneous reactions were evaluated 24 and 48 h after removal of the dressing. Reliability checks were performed regularly to confirm the sensitivity and reliability of the test. The positive control group was exposed to alpha-hexylcinnamaldehyde, which led to signs of skin sensitisation in 6/10 animals. No skin reactions indicative of skin sensitisation were observed in the animals treated with fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters. Therefore, the test substance is not considered to exhibit a skin sensitising potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation for an adequate analogue source substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are conclusive but not sufficient for classification. Based on an analogue read-across approach, the target substance docosyl docosanoate (CAS 17671-27-1) is, therefore, also not classified for skin sensitisation.
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