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EC number: 211-546-6 | CAS number: 661-19-8
- 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:
- March, 15th - May, 12th 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Icosan-1-ol (629-96-9) and Docosan-1-ol (661-19-8)
- IUPAC Name:
- Icosan-1-ol (629-96-9) and Docosan-1-ol (661-19-8)
- Test material form:
- solid
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 Nossan S.r.l., Correzzana (MI), Italy
- Age at study initiation: 5 -6 weeks
- Weight at study initiation: 672.9 ± 61.9 g (control), 629.9 ± 62.0 g (test group)
- Housing: stainless steel cages (48x63x41 cm) with a grid floor in groups of 5 animals
- Diet: commercially available laboratory diet (Altromin MSK) ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2000-03-15 To: 2000-05-12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 5% test substance in vehicle or Freund's complete adjuvant for intradermal induction
75% test substance in vehicle for topical induction
10% test substance in vehicle for challenge
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 5% test substance in vehicle or Freund's complete adjuvant for intradermal induction
75% test substance in vehicle for topical induction
10% test substance in vehicle for challenge
- No. of animals per dose:
- Range finding: 2 for injection tolerance test, 5 for topical tolerance test
Main test: 10 for test group, 5 for control group - Details on study design:
- RANGE FINDING TESTS:
Intradermal injection tolerance test: 0.1 ml of the test item in concentrations of 10, 5, 1, 0.5, 0.1 and 0.05% in vehicle injected intradermally, evaluation after 6 days
Topical application tolerance test: with 0.1 ml of emusified Freund's complete adjuvant (FCA) intradermally injected animals (2 injections) were treated topically for 24 hrs (epicutaneous, occlusive, duplicate application) after 8 days with concentrations of 75, 50, 20, 10 and 5% test substance in vehicle, evaluation 24 and 48 hours after removal of dressings
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period:
Intradermal: single application, skin reactions assessed approx. 24 hrs after injection
Epicutaneous: 48 hrs, evaluation 24 hrs after patch removal
- Test groups:
Intradermal: 3 pairs of injections (0.1 ml each) at anterior, median and posterior positions; anterior: emulsified FCA, median: test substance in corn oil, posterior: test substance in emulsified FCA
Epicutaneous: 0.4 ml of test substance in corn oil (the day before 0.5 ml of sodium lauryl sulphate at 10% concentration was spread evenly over the skin surrounding the injections sites)
- Control group: Animals of the control group were treated in the same manner except that the test item was replaced by vehicle alone
- Site:
Intradermal: scapular region over an area approx. 20 x 40 mm, all injections were made at the edge of the prepared site and the anterior and median injections were positioned close together and distant from the posterior injections
Epicutaneous: gauze patches were covered with the test solutions (0.4 ml each) and placed over the injection sites, this was covered with strips of aluminium foils and the animals were then wrapped with lengths of elastic adhesive bandages
- Frequency of applications: Day1: intradermal injections, Day7: pretreatment with sodium lauryl sulphate, Day8: epicutaneous application
- Duration: 3 weeks
- Concentrations:
Intradermal: 5% in corn oil, 5% in emulsified FCA
Epicutaneous: 75% in corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 hrs
- Test groups: 0.2 ml aliquots of the test substance in corn oil on patches of gauze measuring 20x20 mm were applied on the right flank of each animal, the left flank of each animal was similarly treated with 0.2 ml of vehicle (petrolatum) alone
- Control group: same treatment as test substance animals
- Site: clipped flanks, area approx. 50x50 mm on each flank
- Concentrations: 10% in corn oil
- Evaluation: 48 and 72 hrs after challenge (24 and 48 hrs after removal of dressings) - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
- Positive control results:
- Most recent reliability check performed in September/October 1999.
Concentrations:
Induction: 1% positive control substance in PEG 400 (injection); 50% positive control substance in acetone (topical)
Challenge: 25% positive control substance in acetone
100% response in test group and 0% response in control group at challenge: test system regarded as valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% positive control substance in acetone
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25% positive control substance in acetone
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge.
- Executive summary:
The potential of the test item, NAFOL 2022, to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the maximisation test of Magnusson and Kligman.
The concentrations of the test item used in the main study were determined by the results of preliminary screening tests. The main sensitisation test was undertaken using a test group of 10 animals and a control group of 5 animals. In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant (FCA) and the test item at 5% concentration in both the selected vehicle and an emulsion of FCA. One week later this was boosted by topical application of the test item at 75% concentration over the injection sites. Control group animals were treated in the same manner but the selected vehicle (corn oil) was used in place of the test item. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle (petrolatum) and the test item at 10% concentration.
At challenge no response to the test item was observed in any animal of the test or control groups following topical exposure to the test item at 10% concentration. No reaction to the vehicle alone was observed in any animal of test or control groups.
These results indicate that the test item, NAFOL 2022, does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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