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EC number: 812-962-6 | CAS number: 34354-88-6
- 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:
- 1994-10-31 to 1994-12-02
- 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:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- December 1992
- Qualifier:
- according to guideline
- Guideline:
- other: "Allergic Contact Dermatitis in the Guinea-Pig: Identification of Contact Allergens"
- Version / remarks:
- Magnusson B. Kligman A.M., 1970 published by C.C. Thomas, Springfield, Illinois, USA.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT study conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force.
Moreover, no indication for skin sensitisation was observed in this study and thus, no dose response information is needed. As described in OECD guideline 406, the LLNA is able to detect reliably moderate to strong sensitisers. Because the test substance is unlikely to be a sensitiser, the GPMT was considered appropriate. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- Ceramide III
- IUPAC Name:
- Ceramide III
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Ceramide III
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable at room temperature in the dark
- Solubility and stability of the test substance in the vehicle: stable for at least 4 hours in propylene glycol
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test substance was prepared in propylene glycol (w/w) prior to each treatment. No adjustment was made for specific gravity of vehicle. The test substance was homogenised using a mechanical stirrer and electric blender.
- Final preparation of a solid: 1, 5, 10 and 25 % (w/w)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species/strain: albino guinea pigs / Himalayan strain, SPF-quality
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 369 – 500 g (excluding positive control group)
- Housing: in pairs in labelled metal cages with wire-mesh floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet (e.g. ad libitum): guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-B, pellet diameter 4 mm (Hope farms, Worden, The Netherlands), ad libitum. Hay (B.M.I., Helmond, The Netherlands) was provided once a week.
- Water (e.g. ad libitum): Tap water diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 %
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
- Air changes per hour: 15
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction: 5 % (w/w) of the test item, in propylene glycol
Dermal induction: 25 % (w/w) of the test item, in propylene glycol - Day(s)/duration:
- 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Challenge:10 %, 5 %, 2 % (w/w) of the test item, in propylene glycol
- Day(s)/duration:
- 3
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in the test group: 10
Number of animals in the negative control group: 5
Number of animals in the dose range finding study: 4 - Details on study design:
- RANGE FINDING TESTS:
Intradermal Injections (one animal):
A 1 % and 5 % (w/w) test item concentration in propylene glycol were injected into injection sites (0.1 mL each) in the right and left clipped shoulder regions, respectively. The resulting dermal reactions were assessed 24 and 48 hours later for erythema, necrosis and diameter of necrosis.
Epidermal Application (same animal as mentioned above):
A 25 % (w/w) test item concentration in propylene glycol (0.5 mL) was applied epidermally on a shaved flank, using a Scotchpak-non-woven patch (2.5 x 2.2 cm) on Micropore tape (both 3M, St. Paul, USA) and held in place by Coban elastic bandage (3M, St. Paul, USA). After 24 hours, the dressing was removed and residual test substance removed using a tissue moistened with tap water. The treated skin was assessed 24 and 48 hours later.
Epidermal Application (three animals):
Four concentrations of the test substance in propylene glycol (25 %, 10 %, 5 % and 1 % w/w, 0.05 mL each) were applied occlusively on a shaved flank of each of the three animals, using Square chambers (v.d. Bend, Brielle, The Netherlands), mounted on Micropore tape and held in place by Coban elastic bandage. After 24 hours, the dressing was removed and residual test substance removed using a tissue moistened with tap water. The treated sites were assessed for erythema and oedema 24 and 48 hours later.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal (day 1)
- No. of exposures: 3 pairs of intradermal injections of 0.1 mL
Test group:
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: a 5 % concentration of the test item in propylene glycol
Injection 3: a 0.5 % concentration of the test item formulated in a 1:1 mixture (v/v) FCA/water
Control group:
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: 100 % propylene glycol
Injection 3: a 50 % (v/v) formulation of propylene glycol in a 1:1 (v/v) mixture FCA/water
Topical Application (day 8)
The shoulder region of the same animals was shaved again one day before the treatments and rubbed with 10 % sodiumdodecylsulfate (SDS, Boom, Meppel, The Netherlands) in petrolatum using a spatula.
Test Group:
The test item was suspended in propylene glycol at a concentration of 25 %. A patch (2 x 4 cm) was fully loaded with 0.5 mL of the prepared test item, applied to the test area and held in contact by an occlusive dressing for 48 hours. After 48 hours, the dressing was removed and residual test substance removed using a tissue moistened with tap water.
Control Group:
SDS 10 % treatment as described above.
A patch was fully loaded with 0.5 mL of the vehicle propylene glycol and applied to the test area and held in contact by an occlusive dressing for 48 hours.
B. CHALLENGE EXPOSURE (day 22)
Test and Control Group:
All animals were treated epidermally with 0.05 mL of each of the following test substance concentrations 10 %, 5 % and 2 %, w/w in propylene glycol and with the vehicle on the clipped and shaved flank, using Square chambers attached to Micropore tape and secured with Coban elastic bandage. After 24 hours, the dressing was removed and residual test substance removed using a tissue moistened with tap water. The skin reaction was observed and recorded 24 and 48 hours after patch removal.
For further information, please see section "any other details on materials and methods incl. tables". - Challenge controls:
- 5 animals challenged in the same manner without induction
- Positive control substance(s):
- yes
- Remarks:
- α-hexyl cinnamic aldehyde, 85%, was dissolved in physiological saline (intradermal induction) or in distilled water (challenge). For epidermal induction, undiluted test substance was used.
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive control substance α-hexyl cinnamic aldehyde, 85 %, was 100 %, confirming the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: No information given. Thus, it is assumed that the results refer to the second reading.
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No information given.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: No information given. Thus, it is assumed that the results refer to the second reading.
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No information given.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: No information given. Thus, it is assumed that the results refer to the second reading.
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No information given.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: No information given. Thus, it is assumed that the results refer to the second reading.
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No information given.
- Remarks on result:
- other: in the 0 % group, no signs of skin sensitisation were observed.
Any other information on results incl. tables
Preliminary Study
The 25 % test substance concentration was chosen as the highest useable concentration, as higher concentrations were not homogeneous. The intradermal injections with a 5 % and 1 % concentration resulted in slight to well-defined erythema and some necrosis. Therefore, a 5 % concentration was selected for the intradermal induction.
The epidermal application with 0.5 mL of a 25 % concentration resulted in slight erythema at both reading times. Therefore, the 25 % concentration was selected for the epidermal induction.
The epidermal application with a series of concentrations (25 %, 10 %, 5 % and 1 %) using Square chambers resulted in two animals with slight erythema in response to the 25 % concentration and in one animal with slight erythema in response to the 10 % concentration. No skin reactions were observed in response to the other concentrations. Therefore, the 10 % concentration was selected as the highest concentration for the challenge.
The selection of the test substance concentration for the main study was based on the results of the preliminary study and in accordance with Magnusson and Kligman (1969).
No signs of systemic toxicity were observed during the preliminary study. However, body weight loss was noted in one of the four animals.
Main Study – Induction
Two experimental animals showed slight erythema after the 48 hours occluded epidermal induction exposure. One control animal showed very small crusts in the treated skin area.
Main Study - Challenge
Control Group: No skin reactions were evident after the challenge exposure.
Experimental Group: No skin reactions were evident after the challenge exposure.
Toxicity symptoms / Mortality
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study during the study period.
Body Weights
The average body weight gain of the control animals was markedly lower than of the experimental animals. No reason can be given for the cause of the difference.
Data on skin reactions from the preliminary study are shown in Table 1a-c.
In the main study induction phase, two animals showed slight erythema after the 48 hours occluded epidermal induction exposure. One control animal showed very small crusts in the treated skin area. No skin reactions were evident after the challenge exposure.
Table 1a: Preliminary study: intradermal injection (one animal)
24 h reading |
Concentration % (w/w) |
Erythema score |
Necrosis |
Diameter (mm) |
|
1 % |
1 |
yes |
2 |
|
5 % |
1 |
yes |
2 |
48 h reading |
Concentration % (w/w) |
Erythema score |
Necrosis |
Diameter (mm) |
|
1 % |
2 |
yes |
2 |
|
5 % |
2 |
yes |
2 |
Table 1b: Preliminary study: epidermal application using scotchpak-non-woven patch (same animal as used for intradermal injection)
24 h reading after bandage removal |
Concentration % (w/w) |
Erythema score |
Oedema score |
|
25 % |
1 |
0 |
48 h reading after bandage removal |
Concentration % (w/w) |
Erythema score |
Oedema score |
|
25 % |
1 |
0 |
Table 1c: Preliminary study: epidermal application using square chambers (3 animals)
24 h reading after bandage removal |
Concentration % (w/w) |
Erythema score |
Oedema score |
|
25 % |
1/3 animals: 1 |
0 |
|
10 % |
0 |
0 |
|
5 % |
0 |
0 |
|
1 % |
0 |
0 |
48 h reading after bandage removal |
Concentration % (w/w) |
Erythema score |
Oedema score |
|
25 % |
1/3 animals: 1 |
0 |
|
10 % |
1/3 animals: 1 |
0 |
|
5 % |
0 |
0 |
|
1 % |
0 |
0 |
Intradermal induction: 5% (w/w) of the test item, in propylene glycol
Dermal induction: 25% (w/w) of the test item, in propylene glycol
Challenge:10%, 5%, 2% (w/w) of the test item, in propylene glycol
POSITIVE CONTROL
α-hexyl cinnamic aldehyde, 85 %, was dissolved in physiological saline (intradermal induction) or in distilled water (challenge). For epidermal induction, undiluted test substance was used. See Table 2 for results.
Table 2: Skin reactions to positive control (10 animals in the test group).
|
α-hexyl cinnamic aldehyde concentration |
|||
|
10 % |
5 % |
2 % |
0 % |
Animals with skin reactions (scores 1-4) |
10 |
10 |
10 |
0 |
Control animals with skin reactions (scores 1 only) |
5 |
3 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions used in this study, no positive skin reactions were observed in any of the animals after the challenge exposure. The test item is therefore considered not to be a dermal sensitizer.
- Executive summary:
In this skin sensitization study according to OECD Guideline No. 406 (adopted 17 July 1992) and EEC Directive 92/69/EEC, Part B.6 (December 1992), it was evaluated whether Ceramide III induces skin hypersensitivity in guinea pigs after intradermal and epidermal exposure.
After assessment of the slightly irritating and the non-irritating test substance concentrations in a preliminary study, a main study was performed with the selected test substance concentrations. Ten animals were intradermally injected with a 5 % concentration and epidermally exposed to a 25 % concentration, while five control animals were treated similarly, but with the vehicle only. Immediately after epidermal exposure, the skin irritation was scored. Two weeks after the epidermal application all animals were challenged with test substance concentrations of 10 %, 5 % and 2 %, and the vehicle propylene glycol. The challenge reactions were assessed 24 and 48 hours after bandage removal.
The epidermal exposure to Ceramide III in the induction phase resulted in slight erythema in two experimental animals only. The epidermal exposure to Ceramide III in the challenge phase resulted in no positive reactions in response to any of the concentrations tested.
Under the conditions of this study, Ceramide III induced no skin sensitisation in guinea pigs and is therefore considered to be a non-sensitizer.
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