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EC number: 246-115-1 | CAS number: 24271-12-3
- 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:
- 22 Jun 2018 - 02 Nov 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted within the OECD guideline and followed GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In vitro methods for assessing sensitisation potential are available but cannot yet fully substitute the animal tests. The sensitivity and reliability of the experimental technique is assessed on a regular basis using mercaptobenzothiazole, which is recommended by the OECD 406 and is known to have moderate skin sensitisation properties.
Test material
- Reference substance name:
- Octadecyl docosanoate
- EC Number:
- 246-115-1
- EC Name:
- Octadecyl docosanoate
- Cas Number:
- 24271-12-3
- Molecular formula:
- C40H80O2
- IUPAC Name:
- octadecyl docosanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl: HA - Guinea Pigs (full barrier)
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known: Not reported
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 330 - 376 g
- Housing: The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to autoclaved hay and to Altromin 3122 maintenance diet
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: At least 5 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): At least 10 changes/ hour
- Photoperiod (hrs dark / hrs light): 12 h: 12 h (light: dark)
- IN-LIFE DATES: Not reported
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 10 mL (w/v).
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 10 mL (w/v).
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
1 animal was treated intradermally with concentrations of 0.75% and 0.5% of the test item suspended with cotton seed oil
1 animal was treated topically with concentrations of 40% and 60% of the test item suspended with cotton seed oil for 24 hours
1 animal was treated topically with concentrations of 60% and 60% of the test item suspended with cotton seed oil for 24 hours
1 animal was treated topically with concentrations of 60% and 60% of the test item suspended with cotton seed oil for 48 hours
MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: 2 - Exposure period: 48 hours - Test groups: 10 animal - Control group: 5 - Site: shoulder region
- Frequency of applications: 3 - Duration: 48 hours - Concentrations: 60% B. CHALLENGE EXPOSURE - No. of exposures: 1 - Day(s) of challenge: 21 - Exposure period: 24 hours - Test groups: 10 animals - Control group: 5 animals - Site: The flanks
- Concentrations: 60% - Evaluation (hr after challenge): 24 & 48 hours OTHER: n/a - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole, purity > 98%, Sigma-Aldrich, lot no.: BCBS4978V, expiry date: 09/2020: 2% induction I phase, 25% induction II phase, 15% challenge
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 80%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythema grade 1 and 2
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 80%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythena grade 1 and 2
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 2. Challenge Exposure
Challenge Concentrations of Test Substance: 60% |
||
|
Number of Animals Showing Skin Reactions after |
|
24 hours |
48 hours |
|
Test group |
0 |
0 |
Negative- control group |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neither erythema nor oedema was observed in any animal at any time of observation. There was no evidence of sensitisation and the percentage of sensitised animals was 0%. Under the conditions of the present study it can be stated that the test item Octadecyl docosanoate caused no reactions identified as sensitisation at the tested concentration. According to Commission Regulation (EU) No 286/2011 as well as GHS (Globally Harmonized Classification System), the test item Octadecyl docosanoate has no obligatory labelling requirement for skin sensitisation and is unclassified.
- Executive summary:
OECD 406 - 2018: In a preliminary study 4 animals were treated with the test item suspended in cotton seed oil; animal 1 treated intradermally with concentrations of 0.75% and 0.5%, animal 2 treated topically with concentrations of 40% and 60% for 24 hours , animal 3 treated topically with concentrations of 60% and 60% for 24 hours and animal 4 treated topically with concentrations of 60% and 60% for 48 hours.
The concentration of 0.75% caused slight signs of irritation, without leading to systemic effects. The dermal application of 60% did not cause signs of irritation or systemic effects after a treatment period of 48 hours and was chosen for topical induction. A concentration of 60% was found to be the highest tested dose which did not cause any signs of irritation after a topical treatment over a period of 24 hours and therefore was chosen for the challenge application in the main test.
Based on the results of this preliminary test, a concentration of 0.75% was chosen for the intradermal application of the main test and a concentration of 60% was selected for the dermal induction.
Main experiment:
Induction: First Stage, Intradermal Injection
Three pairs of intradermal injections of 0.1 mL volume were given in the clipped shoulder region;
Test Group: Day 0
Injection 1: a 1:1 mixture (v/v) FCA / physiological saline 0.9% NaCl
Injection 2:a 0.75% concentration of the test item in cottonseed oil
Injection 3: a 0.75% concentration of the test item formulated in a 1:1 mixture (v/v) FCA / physiological saline 0.9% NaCl
Control Group: Day 0
Injection 1: 1:1 mixture (v/v) FCA / physiological saline 0.9% NaCl
Injection 2: a 100% cottonseed oil
Injection 3: a 50% (v/v) formulation of cottonseed oil in a 1:1 (v/v) mixture FCA / physiological saline 0.9% NaCl
Induction: Second Stage, Topical Application
Test Group Day 7: The test item was suspended with cottonseed oil at a concentration of 60%. A patch was fully loaded with 0.5 mL of the prepared test item. Then it was applied to the test area and held in contact with the help of an occlusive dressing for 48 hours.
Control Group Day 7: A patch was fully loaded with 0.5 mL of cottonseed oil. Then it was applied to the test area and held in contact with the help of an occlusive dressing for 48 hours.
Challenge: Topical Application
Test Group and Control Group: Day 21
The test item was suspended with cottonseed oil at a concentration of 60%. A patch loaded with 0.5 mL of the prepared test item was applied to the left flank of the animals and a patch loaded with 0.5 mL of the vehicle to the right flank (intraspecific control). The patches were held in contact with the help of an occlusive dressing for 24 hours. The application area was not rinsed.
Approximately 21 hours after removing the patch, the challenge area was cleared of hair by the use of a depilatory cream. Approximately 24 and 48 hours after removing the patch the skin reaction was observed and recorded according to the grades shown below.
Additionally all animals were observed for signs of toxicity at least once daily during the test period.
Result:
All animals survived throughout the study. One control animal exhibited clinical signs such as moderately reduced spontaneous activity, scratches on the back, a bite wound on the neck and residual dirt around the eyes on study day 7. Slightly reduced spontaneous activity and residual dirt around the eyes was observed on study day 8. Scratches on the back were noted from day 7 to day 16, a bite wound on the neck observed from day 7 to day 11 was replaced by crust on the neck from day 12 to day 16 of the study. From study day 17 no clinical signs were observed any more.
Body weight development was within the expected range for all animals.
Grade 1 erythema and oedema was observed in both control and treated animals during induction phase, this was considered effect of dressing not treatment related.
Neither erythema nor oedema was observed in any animal at any time of observation. There was no evidence of sensitisation and the percentage of sensitised animals was 0%.
Conclusion:
Under the conditions of the present study it can be stated that the test item Octadecyl docosanoate caused no reactions identified as sensitisation at the tested concentration. According to Commission Regulation (EU) No 286/2011 as well as GHS (Globally Harmonized Classification System), the test item Octadecyl docosanoate has no obligatory labelling requirement for skin sensitisation and is unclassified.
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