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EC number: 600-337-9 | CAS number: 102691-36-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Sept 12th 2019 to December 6th 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-({bis[bis(propan-2-yl)amino]phosphanyl}oxy)propanenitrile
- EC Number:
- 600-337-9
- Cas Number:
- 102691-36-1
- Molecular formula:
- C15H32N3OP
- IUPAC Name:
- 3-({bis[bis(propan-2-yl)amino]phosphanyl}oxy)propanenitrile
- Test material form:
- liquid
- Details on test material:
- clear, colourless liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Age at the Initiation of Dosing: Young adult animals (approximately 10 weeks old) were selected.
Weight at the Initiation of Dosing: 18.3 to 24.5 g.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Two test item concentrations were tested; a 50% and 100% concentration.
- No. of animals per dose:
- 5 females
- Details on study design:
- Three groups of five animals were treated with one test item concentration per group. The highest test item concentration was selected from the pre-screen test. One group of five animals was treated with the vehicle.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI values calculated for Alpha- Hexylcinnamaldehyde, technical grade (CAS no. 101-86-0) at concentration of 5, 10 and 25% were 0.7, 2.2 and 6.4 respectively. An EC3 value of 12.8% was calculated using linear interpolation.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Remarks:
- as a percentage
- Value:
- 52.6
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 19.4
- Test group / Remarks:
- 100%
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- These results show that the test item elicits a SI ≥ 3. An EC3 value (the estimated test item concentration that will give a SI =3) of 52.6% was calculated.
The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at the Test facility is an appropriate model for testing for contact hypersensitivity
Based on these results:
- According to the recommendations made in the test guidelines (including all amendments), the substance would be regarded as skin sensitizer.
- According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), the substance should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction. - Executive summary:
The objective of this study was to evaluate whether the substance induces skin sensitization in mice after three epidermal exposures of the animals under the conditions described.
The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at the test facility is an appropriate model for testing for contact hypersensitivity.
Test item concentrations selected for the main study were based on the results of a pre-screen test. Based on the results, the highest concentration required according to the guidelines was
selected. In the main study, three experimental groups of five female CBA/J mice were treated with test item concentrations of 25, 50 or 100% w/w on three consecutive days, by open
application on the ears. Five vehicle control animals were similarly treated, but with the vehicle alone (Acetone/Olive oil). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was subsequently calculated
for each group.
The majority of auricular lymph nodes were considered normal in size, except for the nodes in the animals of 100% which were considered slightly enlarged in size. No macroscopic
abnormalities of the surrounding area were noted for any of the animals. Mean DPM/animal values for the experimental groups treated with test item concentrations 25, 50 and 100% were 888, 1565 and 14635 DPM, respectively. The mean DPM/animal value for the vehicle control group was 755 DPM. The SI values calculated for the test item concentrations 25, 50 and 100% were 1.2, 2.1 and 19.4, respectively. These results show that the test item elicits a SI ≥ 3. An EC3 value (the estimated test item concentration that will give a SI =3) of 52.6% was calculated.
Based on these results:
- According to the recommendations made in the test guidelines (including all amendments), the substance would be regarded as skin sensitizer.
- According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), the substance should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction.
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