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EC number: 604-714-9 | CAS number: 149968-48-9
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 1st March to 21 April 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed similarly to the OECD 406 guideline. No positive control was used in this study and there was no reference to historical positive control data and only 10 and 5 animals were used in the treated and the control groups, respectively. The test was performed on a very similar structure (saturated chain instead of an insaturated chain).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no positive control data, only 10 animals in the treated group
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- -
Test material
- Reference substance name:
- Docosanamide,N-[3-(dimethylamino)propyl]-
- IUPAC Name:
- Docosanamide,N-[3-(dimethylamino)propyl]-
- Reference substance name:
- N-[3-(dimethylamino)propyl]docosanamide
- EC Number:
- 262-134-8
- EC Name:
- N-[3-(dimethylamino)propyl]docosanamide
- Cas Number:
- 60270-33-9
- Molecular formula:
- C27H56N2O
- Test material form:
- other: white powder
- Details on test material:
- - Name of test material (as cited in study report): 04-S-014
- Storage condition of test material: a dark place at room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc. Japan
- Age at study initiation: 4 weeks
- Weight at study initiation: 336g
- Housing: group of 5 animals in aluminium cages (W350 x D400 x H230)
- Diet (e.g. ad libitum): solid food (RC4: Oriental YEast Co., Ltd), ad libitum
- Water (e.g. ad libitum): tap water after passing 5µm wartridge filter, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2°C
- Humidity (%): 50 +/- 10%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal injection: physiological saline (Lot 3I86 Otsuka Pharmaceutical Factory Inc.); contact sensitization and challenge: 50% ethanol in water (Lot. AFE2540 Wako Pure Chemical Industries Ltd.)
- Concentration / amount:
- intradermal sensitisation: 0.01% test substance in physiological saline or an emulsion of 0.02% test substance in physiological saline and FCA in 1:1
Contact sensitisation: 30%
Challenge: From 0.5 to 30%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal injection: physiological saline (Lot 3I86 Otsuka Pharmaceutical Factory Inc.); contact sensitization and challenge: 50% ethanol in water (Lot. AFE2540 Wako Pure Chemical Industries Ltd.)
- Concentration / amount:
- intradermal sensitisation: 0.01% test substance in physiological saline or an emulsion of 0.02% test substance in physiological saline and FCA in 1:1
Contact sensitisation: 30%
Challenge: From 0.5 to 30%
- No. of animals per dose:
- 8 animals for the preliminary test
10 for the sensitisation group
5 for the control group - Details on study design:
- RANGE FINDING TESTS:
a) 0.1 mL of test substance at concentration comprised between 0.01 and 5% was intradermally injected in the lateral abdomen of 4 animals.
b) closed patches with 0.05 mL of each test sample (6 tested concentrations comprised between 0.3 and 10% in ethanol) were applied on four symetric sites on the back of 4 animals. One week before, these animals were intradermally treated with the test susbtance and FCA). The contact sensitisation was made under occlusive conditions for 24 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (a, b and c) x2 sites (for intradermal injection)
- Exposure period: d0-d8
- Test groups:
a) an emulsion of FCA and physiological saline in 1:1
b) 0.01% TS in vehicle (physiological saline)
c) 0.02% TS and FCA in 1:1
- Control group: vehicle (physiological saline)
- Site: 2 sites (right and left) on the back
- Frequency of applications: Topical induction 8 days after intradermal one
- Duration: Acute (intradermal) / 48 h (topical)
- Concentration: intradermal injection:0.01% TS, contact sensitisation: 30% TS.
On day 8 from initiation of sensitisation, 0.2 mL of the sample was soaked in lint cloth of 2x4 cm in size and applied as a closed patch for 48 hours using occlusive patch.The control animals were treated similarly using the vehicle (50% ethanol in water). Since the test substance is non-irritating, 0.5 g of 10% SDS was applied on day 7.
B. CHALLENGE EXPOSURE
- No. of exposures: 1x6 sites
- Day(s) of challenge: d21
- Exposure period: 24 hours
- Test groups: TS
- Control group: TS
- Site: lateral abdomen
- Concentrations: 6 different (from 0.5 to 30%): 0.5; 1; 3; 5; 10 and 30%
- Evaluation (hr after challenge): 3, 24 and 48 hours after the patch removal
OTHER: To assess the skin reactions after the closed patch in the preliminary assay and after the challenge in the main study, the Draize scale was followed. - Challenge controls:
- not applicable
- Positive control substance(s):
- no
- Remarks:
- no positive control was used in the study and no reference to positive historical data was made.
Results and discussion
- Positive control results:
- not applicable as no positive control was used.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 0.5 to 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- score for erythema and edema= 0 for all treated animals at any tested concentration
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 3.0. Group: test group. Dose level: 0.5 to 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: score for erythema and edema= 0 for all treated animals at any tested concentration.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 to 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- score for erythema and edema= 0 for all treated animals at any tested concentration
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 to 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: score for erythema and edema= 0 for all treated animals at any tested concentration.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 to 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- score for erythema and edema= 0 for all treated animals at any tested concentration
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 to 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: score for erythema and edema= 0 for all treated animals at any tested concentration.
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- negative control
- Dose level:
- 0.5 to 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- score for erythema and edema= 0 for all control animals at any tested concentration
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 3.0. Group: negative control. Dose level: 0.5 to 30%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: score for erythema and edema= 0 for all control animals at any tested concentration.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 to 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- score for erythema and edema= 0 for all control animals at any tested concentration
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 to 30%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: score for erythema and edema= 0 for all control animals at any tested concentration.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 to 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- score for erythema and edema= 0 for all control animals at any tested concentration
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 to 30%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: score for erythema and edema= 0 for all control animals at any tested concentration.
Any other information on results incl. tables
Results of the preliminary test:
Table 7.4.1/1:result of primary skin irritation after the intradermal administration
At observation |
24 hrs after administration |
48 hrs after administration |
72 hrs after administration |
|||||||||||||||||||
Samples |
i |
ii |
iii |
iv |
v |
vi |
vii |
i |
ii |
iii |
iv |
v |
vi |
vii |
i |
ii |
iii |
iv |
v |
vi |
vii |
|
Animal No. |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
|
Judgment |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
± |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
1 |
4 |
|
+ |
0 |
0 |
0 |
0 |
1 |
2 |
2 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
|
++ |
0 |
0 |
0 |
0 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
2 |
0 |
|
+++ |
4 |
4 |
4 |
4 |
0 |
0 |
0 |
4 |
4 |
4 |
4 |
0 |
0 |
0 |
4 |
4 |
4 |
4 |
0 |
0 |
0 |
i: 5%; ii: 1%; iii: 0.5% ; iv: 0.1% ; v: 0.05% ; vi: 0.03%; vii: 0.01%
-: no reaction; ±: slight erythema; +: apparent erythema; ++: apparent erythema with edema; +++: eschar formation and necrosis
Table 7.4.1/2:result of primary skin irritation after the 24-hour closed patch application
Concentration of TS (%) |
Observation time after patch removal (hr.) |
Erythema score |
Edema score |
||||||||
0 |
1 |
2 |
3 |
4 |
0 |
1 |
2 |
3 |
4 |
||
10 |
3 |
0 |
4 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
24 |
0 |
4 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
48 |
0 |
4 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
5 |
3 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
24 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
48 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
3 |
3 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
24 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
48 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
1 |
3 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
24 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
48 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
0.5 |
3 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
24 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
48 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
0.3 |
3 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
24 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
|
48 |
4 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
Main test:
No abnormalities in the general conditions was observed after sensitisation or challenge during the study period and the animals showed satisfactory body weight increases.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Erucamidopropyl dimethylamine is not sensitising in the guinea-pig maximisation test. Erucamidopropyl dimethylamine is therefore not classified for skin sensitisation according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.
- Executive summary:
In a Guinea-Pig Maximisation Test performed similarly to OECD No. 406 test guideline,Docosanamide,N-[3-(dimethylamino)propyl]-(purity of 99%) was tested for its skin sensitising potential in Albino Hartley female guinea pigs.
A preliminary test on 4 animals using intradermal injections of the test substance in physiological saline at concentration from 0.01 to 5% showed that higher concentration than 0.01% induced skin irritation with the presence of erythema and edema. The concentration of 0.01% only induced a mild skin irritation. Therefore the intradermal induction concentration was chosen as 0.01% for the main test.
In 4 another animals, several concentrations from 0.3 to 10% were tested by topical application during 24hrs one week after intradermal injection of the test substance in emulsion with Freund’s Complete Adjuvant (FCA). Only the highest concentration (10%) induced a slight skin irritation (erythema score of 1). A range of challenging concentration between 0.5 and 30% was chosen for the main test.
For the main test, 5 animals were applied the vehicle (physiological saline) only (control group) and 10 other animals were applied the test substance. For the induction phase, animals received two intradermal injections on day 0 (right and left sites of the back) of the vehicle (physiological saline) in FCA or the test substance at 0.01% in physiological saline or the test substance at 0.01% in FCA emulsion. One week later, as the test substance is non-irritating, 0.5 g of 10% SDS was applied. The next day (Day 8), a second induction was performed by a topical application of the test substance at 30% in ethanol. Two weeks after the topical induction phase (day 21), challenge was performed by applying 6 different concentrations (from 0.5 to 30%) of the test substance in ethanol under occlusive conditions for 24 hours. Observation and grading of skin reactions was performed 3, 24 and 48 hours after patch removal to assess potential sensitisation.
No skin reaction and therefore no sign of sensitisation was observed 3, 24 and 48 hours after the challenge in any animal (control or treated groups).
Therefore, under the conditions of this test,Docosanamide,N-[3-(dimethylamino)propyl]-is not considered as a skin sensitiser according to the criteria of the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC (DSD). This study is considered as acceptable and satisfies the requirement for skin sensitization endpoint.
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