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Diss Factsheets
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EC number: 308-415-1 | CAS number: 97953-16-7
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 May 2018 - 29 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17th, 1992
- Deviations:
- yes
- Remarks:
- A relative humidity higher than 70% was registered. A temperature higher than 25°C was registered. As no effect was noted on the health of the animals, this deviation is considered as without impact on the conclusion of the study.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- There are significant concerns raised in the toxicology literature regarding the suitability of the LLNA methodology for the assessment of surfactant substances. The literature recommends that in vivo testing of surfactants for sensitizing potential should be done using one of the available guinea pig test guidelines to insure the highest relevance of the results to humans ie either the Buehler or the GPMT. Generally the latter is considered to be the more rigorous of the two methods since it maximizes the conditions to provoke sensitization. Furthermore in this case the selection of this assay allows the results to be directly compared to the GPMT data on the analogue substances, as part of the discussion on read-across.
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- EC Number:
- 308-415-1
- EC Name:
- 9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- Cas Number:
- 97953-16-7
- IUPAC Name:
- 9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
Constituent 1
- Specific details on test material used for the study:
- Batch No.: RL 55/17
Expiry date: 31 January 2019
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- 5, 6, 7 or 8 weeks old at the beginning of the test.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- Distilled water for topical applications.
- Concentration / amount:
- Intradermic injection at 0.025% and topical application at 10%
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% and diluted at 2.5% in distilled water
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- GROUP 1 (negative control): 10 male guinea pigs.
GROUP 2 (treated): 20 male guinea pigs/dose. - Challenge controls:
- Physiological saline and distilled water.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- Moderate erythema, discrete erythema and no cutaneous reaction was noted in 11, 6 and 3 animals, respectively, 24 hours after first induction. A scab and dryness of the skin was noted in 15 and 5 animals, respectively, after the second induction.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The substance produced positive skin sensitisation results and therefore has to be classified in category 1 (sub-category 1A) as a skin sensitizer.
- Executive summary:
A Guinea Pig Maximisation Test was undertaken to evaluate the possible allergenic activity of the substance after intradermal and topical administration in guinea pigs. The induction phase (intradermic injection at 0.025% and topical application at 10%) was conducted with the substance to 20 Guinea pigs and a 10-day rest phase. The challenge phase conducted under occlusive dressing for 24 hours, consisted of a single topical application of the test item at 5% and diluted at 2.5% in distilled water. In the treated group (treatment dose of 5%), a discrete to intense erythema was noted in 40% (8/20), 35% (7/20) and 25% (5/20) of the animals, 24, 48 and 72 hours after the challenge phase, respectively. In the control group (associated with the treatment dose of 5%), no macroscopic cutaneous intolerance reactions were recorded after the challenge phase. In the treated group (treatment dose of 2.5%), a moderate to intense erythema was noted in 40% (8/20), 30% (6/20) and 20% (4/20) of the animals, 24, 48 and 72 hours after the challenge phase, respectively. In the control group (associated with the treatment dose of 2.5%, no macroscopic cutaneous intolerance reactions were recorded after the challenge phase. In conclusion, under these experimental conditions, the substance produced positive skin sensitisation results and therefore has to be classified in category 1 (sub-category 1A) as a skin sensitizer.
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