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EC number: 418-370-0 | CAS number: 143925-92-2
- 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:
- 1995-06-12 to 1995-09-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- July 31, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Since two valid guinea pig studies are available, no LLNA is necessary.
Test material
- Reference substance name:
- -
- EC Number:
- 418-370-0
- EC Name:
- -
- Cas Number:
- 143925-92-2
- Molecular formula:
- C32-36 H67-74 N1 O1
- IUPAC Name:
- N-hexadecyl-N-octadecylhydroxylamine
- Test material form:
- solid
- Details on test material:
- - State of aggregation: solid
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation:
- Weight at study initiation: 344 to 409 g
- Housing: individually, in Macrolon cages (Type 3)
- Diet (ad libitum): standard guinea pig pellets - NAFAG 845, NAFAG, Gossau/SG, Switzerland
- Water (ad libitum): fresh water
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30 %
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group
- Details on study design:
- RANGE FINDING TESTS:
The concentration for the epidermal applications was selected on account of the primary irritation potential of the test article.
The following concentrations of the test item were examined in pretest animals in duplicate to determine the maximum subirritant concentration: 30 and 50 % (w/v) in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 0 Induction, intradermal
- No. of exposures: Three pairs of intradermal injections (0.1 ml per injection)
- Site:o n the left and right side of the shaved neck
- Frequency of applications: consecutively
- Concentrations:Test group: - adjuvant/physiological saline mixture 1:1 (v/v)
- 5% test item in oleum arachidis
- 5% test item in the adjuvant/physiological saline mixture (w/v)
Control group: - adjuvant/physiological saline mixture 1:1 (v/v)
- adjuvant/physiological saline mixture 1:1 (v/v)
- oleum arachidis
DAY 8: INDUCTION, epidermal
In the test group the test item was suspended in vaseline and applied on a filter paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occlusive dressing for 48 hours).
The control group was treated with the vehicle only.
Test group: - 50 % test item in vaseline
Control group: - vaseline
Induction reactions
- Irritation was examined on day 10, 1 hour after removal of the dressing.
B. CHALLENGE EXPOSURE
- Amount: approx. 0.35 mL per chamber
- Dressing: occlusive
- Exposure period: 24 hours
- Site: both flanks
- Concentrations: Test and control group: - 30% test item in vaseline
- vaseline
- Evaluation (hr after challenge): The challenge reactions were scored 24 and 48 hours after removing the dressings according to the Draize scale - Positive control substance(s):
- yes
- Remarks:
- once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate
Results and discussion
- Positive control results:
- Reference Values with 2-Mercaptobenzothiazole: The reliability check resulted in positive response in 13 (6 males and 7 females) of 20 (appr. 60 %) challenged guinea pigs. There were no irritant skin reactions in control groups. Based on results, 2-Mercaptobenzothiazole is graded as a moderate sensitizer according to Magnusson and Kligman.
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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- erythema (score 1) in 3 female animals
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- erythema (score1 ) in 3 males and 5 females, edema (score 1) in 1 male and1 female
Any other information on results incl. tables
After, removal of the occlusive dressing on day 10 after epidermal induction, irritation at the application site was seen in 19 of 20 guinea pigs of the test groups.
Body weights were not affected by the treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test article was graded as a moderate sensitiser according to the Magnusson and Kligman maximisation scale.
- Executive summary:
A guinea pig maximisation test was initiated to determine sensitising properties of the test material after challenge exposure by skin contact. The procedure of Magnusson and Kligman for adjuvant tests was followed. Epidermal challenge of 10 male and 10 female guinea pigs (test groups) resulted in positive responses in 3 female guinea pigs after 24 hours and in 3 male and 5 female guinea pigs after 48 hours, corresponding to a sensitisation rate of 40%. No irritant skin reactions were recorded for control animals. Body weights at start and on conclusion of the test were unaffected by the treatment. The test article was graded as a moderate sensitiser according to the Magnusson and Kligman maximisation scale.
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