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EC number: 216-510-3 | CAS number: 1604-35-9
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 July 2015 - 19 August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline conformant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 3,7,11-trimethyldodecyn-3-ol
- EC Number:
- 216-510-3
- EC Name:
- 3,7,11-trimethyldodecyn-3-ol
- Cas Number:
- 1604-35-9
- Molecular formula:
- C15H28O
- IUPAC Name:
- 3,7,11-trimethyldodec-1-yn-3-ol
- Details on test material:
- - Name of test material (as cited in study report): 3,7,11-trimethyldodecyn-3-ol
- Test item No.: 05/0025-2
- Physical state: colorless, clear liquid
- Analytical purity: 9.8%
- Lot/batch No.: 40637247G0
- Expiration date of the lot/batch: 29 March 2016
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN, Kreuzelweg 53, 5961 NM HORST, The Netherlands
- Age at study initiation: 3-4 weeks
- Weight at D0 of study: 263.4 - 270.4 g
- Housing: in groups of 2
- Diet: SAFE 106 ad libitum
- Water: ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (+/- 3)
- Humidity (%): 30-70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Animals in treated group were sensitized and challenged with 0.5ml of the test item diluted at 75% in liquid paraffin (MNIC determined in pre-study),
control animals were treated with 0.5ml of liquid paraffin.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Animals in treated group were sensitized and challenged with 0.5ml of the test item diluted at 75% in liquid paraffin (MNIC determined in pre-study),
control animals were treated with 0.5ml of liquid paraffin.
- No. of animals per dose:
- Total animals: 30
Group 1 (negative control): 10 female guinea pigs
Group 2 (treated with test substance): 20 female guinea pigs - Details on study design:
- RANGE FINDING TESTS:
A preliminary study was carried out to dertermine the MNIC. Three guinea pigs were treated with concentrations of 100%, diluted at 75%, 50%, and 25%of test substance in liquid paraffin. Application was performed epicutaneously under occlusive dressing for 6 hours. Cutaneous reaction was
determined 24h and 48h after removal of occlusive dressings. 24 hours after removal of the patches, a discrete erythema (grade 1) in two animals (2/3) was noted at the tested concentration of 100%. No cutaneous reaction was noted in the other animal 48 hours after the removal of the patches, one of these animals still showed discrete erythema, while the other one exhibited dryness of the skin.
24 and 48 hours after removal of the patches, no cutaneous reaction was noted at the other tested concentrations 75%, 50% and 25%.
In view of these results, the concentration selected was 100% for the 3 inductions of the main study and the concentration selected was 75% (MNIC) for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure at D0, D7, D14
- Site: inter-scapular zone
- Duration: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in contact
with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: 100% test substance (treated group), liquid paraffin (control group)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: D28
- Site: dorso-lumbar zone
- Exposure period: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in
contact with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: test item diluted at 75% in liquid paraffin (MNIC) on the left flank or liquid paraffin on the right flank
- Evaluation (hr after challenge): 24h, 48h after removal of occlusive dressing
Grading was perfomed according to OECD 406:
0 = No visible change
1 = Discrete or patchy erythema
2 = Moderate and confluent erythema
3 = Intense erythema and swelling
The number of animals showing visible cutaneous reactions were determined and recorded at 24 and 48 hours after challenge.
The classification "sensitising" results if at least 15% of test animals showed cutaneous reactions at the time of evaluation. The evaluation is based on
the criteria of the OECD Harmonized Integrated Classification System in place on the date of report signature.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Discrete erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Induction phase:
Animals showing cutaneous reactions | |||
1st induction | 2nd induction | 3rd induction | |
Control group (10 animals) | 0 | 0 | 0 |
Treated group | 0 | 0 | 0 |
Challenge phase:
In the treated group (treatment concentration 75% of test item), a discrete erythema was noted in only one animal (1/20) at the reading time 24 hours. No macroscopic cutaneous reactions attributable to allergy were observed 48 hours after the removal of the occlusive dressing.
In the control group, no cutaneous reactions were observed at 24 or 48 hours after removal of occlusive dressing.
No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the area treated with liquid paraffin.
Grading scale | ||||||||
Groups | Reading time | Concentrations | 0 | 1 | 2 | 3 | % positive responses | % of animals sensitized |
Control | 24 hours | 75% | 10 | 0 | 0 | 0 | 0 | |
48 hours | 75% | 10 | 0 | 0 | 0 | 0 | ||
24 hours | 0% | 10 | 0 | 0 | 0 | 0 | ||
48 hours | 0% | 10 | 0 | 0 | 0 | 0 | ||
Treated | 24 hours | 75% | 19 | 1 | 0 | 0 | 5 | 5 |
48 hours | 75% | 20 | 0 | 0 | 0 | 0 | 0 | |
24 hours | 0% | 20 | 0 | 0 | 0 | 0 | 0 | |
48 hours | 0% | 20 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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