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EC number: 203-354-6 | CAS number: 106-02-5
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Table 7.4.1: Summary of skin sensitisation studies:
Test type
Reference
Test item
Purity
Classification
LLNA
Zurney, 2012
ST 11 C 12
98,30%
Sensitizer
Zurney, 2012
ST 12 C 12
100%
NC at non-irritants levels
Zurney, 2012
ST 18 C 18
100%
NC at non-irritants levels
Bradshaw, 2009
Sym 09/689858
>99,8%
NC
Bradshaw, 2009
Sym 09/660539
>98,5%
Sensitizer
Hassler, 2011
Sym10/660539 S
99%
Sensitizer
Hassler, 2010
Sym10/660539 F
98,30%
Sensitizer
GPMT
Bollen, 1997
HR 97/660539
99,60%
NC
Driscoll, 1995
HR 94/660539
99,70%
NC
HRIPT
Eisenberg, 2006
Sym06/660539 Batch 225
98,90%
NC
Thomsen, 1997
HR 97/660539
99,60%
NC
Schrader, 1998
HR 97/660539
99,00%
NC (1/50 individuals showed response)
Two Guinea-pig maximisation tests have been performed on the substance (Bollen, 1997; Driscoll, 1995), both showed an absence of sensitizing potential:
- In a Magnusson & Kligman maximisation study (GPMT) performed by Bollen (1997) according to OECD Guideline 406 and in compliance with GLP, 20 female Dunkin-Hartley guinea pigs were induced with three pairs of intradermal injections (0.1 mL each) of Freund's complete adjuvant (FCA) emulsified 1:1 in sterile water, 10 % (w/w) test item, the test substance in sesame oil and 10 % (w/w) test article formulated in a 1:1 mixture (w/w) of FCA and sesame oil. On Day 8, the same area was topically induced with 50 % test article in Ethanol/diethyl phthalate 1:1 via occluded filter paper patch for 48 h for the treated group. On Day 21, challenge filter paper patch of 25 % (w/w) test article in Ethanol/diethyl phthalate 1:1 or vehicle (Ethanol/diethyl phthalate 1:1) was applied on the left anterior flank and left posterior flank, respectively. Challenge control group was applied with 25 % (w/w) test article in Ethanol/diethyl phthalate 1:1 on the left posterior flank. On Day 29, a rechallenge filter paper patch of 12.5 % (w/w) test article in Ethanol/diethyl phthalate 1:1 or vehicle (Ethanol/diethyl phthalate 1:1) was applied on the right anterior flank and right posterior flank, respectively. Rechallenge control group was applied with 12.5 % (w/w) test article in Ethanol/diethyl phthalate 1:1 on the right posterior flank. The test concentrations for the main study were determined from a sighting study using two animals per exposure. Slight or discrete erythema was observed at the rechallenge sites of test group animals at 24 and 48 h observations. The test substance produced a 0 % (0/19) sensitisation rate and was considered to be a non-sensitiser to guinea pig skin. Under these test conditions, the test item is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).
- In a Magnusson & Kligman maximisation study (GPMT) performed by Driscoll (1995) according to OECD Guideline 406 and in compliance with GLP, 20 male Dunkin-Hartley guinea pigs were induced with three pairs of intradermal injections (0.1 mL each) of Freund's Complete Adjuvant plus distilled water in the ratio 1:1, 5 % w/v dilution of test material in arachis oil B.P, 5 % w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water, on Day 0 on three different sites on each side of the mid-line on shoulder region. After one week the same area was topically induced with undiluted test material via occluded filter paper patch for 48 h for the treated group. After 2 weeks, a challenge filter paper patch of 50 and 75 % v/v in 1:1 ethanol/diethylphthalate test material formulation was applied to the left and right flank, respectively in all animals. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 and 48h observations. The test substance produced a 0 % (0/19) sensitisation rate and was considered to be a non-sensitiser to guinea pig skin. Under these test conditions, the test item is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).
A total of seven LLNA studies have been performed on a variety of samples of the test substance, each with a different identified purity. The test substance seems to generate somme irritation to the skin in the LLNA test and this property may interfere with the accuracy of the LLNA, such that an arbitrary limit of an increase in ear thickness of 25% has been set as the threshold above which sensitizing results should be discounted. In the seven studies results were obtained that indicated that any sensitizing potential that may be detected is seen at a concentration very close to the concentration that also induces irritation at the threshold level. Furthermore, it may be said that generally as the purity of the tested sample increases then the sensitizing potential observed in the LLNA decreases and samples where the purity is 99.8% or greater may be non-classifiable as sensitizers.
Two human repeat insult patch tests and one patch test have been performed on the substance (Eisenberg, 2006; Thomsen, 1997; Schrader, 1998) with a total of 205 patients. All three studies were concluded to be negative for sensitization although 1/50 patients in one of the studies showed a reaction to the challenge.
Migrated from Short description of key information:
The sensitization potential of Pentadecan-15-olide has been investigated in a number of different studies and study types. The substance has been shown to be both sensitizing and non-sensitizing in the LLNA, with the purity of the sample being critical to the outcome of the test. The data indicate that if the substance has a purity ≥ 99.8% then it is not classifiable as a sensitizer. The substance is not sensitizing in the GPMT and not sensitizing in 3 HRIPT studies, although one individual in one study exhibited a response on challenge.
Justification for selection of skin sensitisation endpoint:
No study was selected since a weight-of-evidence approach was followed to conclude on the skin sensitisation potential of Pentadecan-15-olide.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
This information is not available.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No 1272/2008 including ATP3.
Self-classification:
Purity <99.8%:
The substance should be classified as skin sensitiser if the purity is less than 99.8%:
-Skin Sens. sub-category 1B (H317: May cause an allergic skin reaction.) according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP),
- Xi; R43 (May cause sensitization by skin contact) according to the Annex VI of the Directive 67/548/EEC.
Purity ≥ 99.8%:
Based on the available information, if the purity of the test substance is equal to or greater than 99.8% then no additional self-classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.
No information is available regarding respiratory sensitisation.
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