Registration Dossier
Registration Dossier
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EC number: 946-742-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 Mar - 1 Apr 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- / no information on reliability check, less than 20 test and 10 control guinea pigs, no information on positive control reported
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)
- Version / remarks:
- 17 July 1992
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted in 2004, where no validated protocol for the LLNA was available.
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]docosanamide; 2-hydroxypropanoic acid
- Cas Number:
- 221446-54-4
- Molecular formula:
- C30H62N2O4
- IUPAC Name:
- N-[3-(dimethylamino)propyl]docosanamide; 2-hydroxypropanoic acid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
FORM AS APPLIED IN THE TEST: liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc., S, Shizuoaka, Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 336 g
- Housing: 5 animals per cage in aluminium cages (Natsume Seisakusho Co., Ltd), placed on automatic water washing shelves
- Diet: solid food (RC4: Oriental Yeast Co., Ltd.), ad libitum
- Water: filtered tap water (5 µm cartridge filter), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 1 Mar To: 1 Apr 2004
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.01 % (v/v)
0.1 mL/ site - Day(s)/duration:
- single injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 30 % (v/v) in ethanol (50% in water)
- Day(s)/duration:
- 2
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.5, 1, 3, 5, 10, 30% in ethanol (50% in water)
- Day(s)/duration:
- 1
- No. of animals per dose:
- 5 females (control), 10 females (test group)
8 females (range finding) - Details on study design:
- RANGE FINDING TESTS:
- intradermal injections:
doses: 0.01, 0.03, 0.05, 0.1, 0.5, 1 and 5% (in physiological saline)
Injections (0.1 mL of each) were made into the lateral abdomen of the guinea pigs.
- epidermal applications: 0.3, 0.5, 1, 3, 5 and 10 % (in ethanol (50% in water). 0.05 mL of the test article were applied to lateral abdomen of the guinea pigs via the cloth portion of an adhesive plaster.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal:
Injection 1: 1:1 mixture (v/v) FCA/ physiological saline
Injection 2: 0.01% test substance (in physiological saline)
Injection 3: 0.02% test substance and FCA, in a 1:1 mixture (v/v)
Epicutaneous:
30 % test substance in ethanol (50% in water)
- Control group:
Intradermal: the vehicle (physiological saline) was used instead of the test substance
Epicutaneous: ethanol (50% in water) was used
- Site: lateral abdomen (intradermal and epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0 - 10
- Concentrations: intradermal 0.01%, epicutaneous 30%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance in ethanol (50% in water)
- Control group: test substance in ethanol (50% in water)
- Site: lateral abdomen
- Concentrations: 0.5, 1, 3, 5, 10 and 30% in ethanol (50% in water)
- Evaluation (hr after challenge): 3, 24 and 48 h - Challenge controls:
- the control group is actually a challenge control
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control was used
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 0.5, 1, 3, 5, 10 and 30% in ethanol (50% in H2O)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- intradermal induction: 0.01% challenge: 0.5, 1, 3, 5, 10 and 30% in ethanol (50% in H2O)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 0.5, 1, 3, 5, 10 and 30% in ethanol (50% in H2O)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 0.01%; challenge: 0.5, 1, 3, 5, 10 and 30% in ethanol (50% in H2O)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 0.5, 1, 3, 5, 10 and 30% in ethanol (50% in H2O)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 0.01%; challenge: 0.5, 1, 3, 5, 10 and 30% in ethanol (50% in H2O)
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
Range finding test
Intradermal injection
4 female guinea pigs were tested using different concentrations (0.01, 0.03, 0.05, 0.1, 0.5, 1 and 5 % in physiological saline) of the test substance and were checked for erythema and oedema after 24, 48 and 72h after the application.
24 h after the injections with 0.01% of the test substance 2 animals showed slight erythema and 2 animals an apparent erythema. At a concentration of 0.03% in 2 animals an apparent erythema was observed and in 2 animals an apparent erythema with oedema, whereas 1 animal showed an apparent erythema and 3 animals an apparent erythema with oedema after treatment with 0.05% of the test substance.
All 4 animals showed eschar formation or necrosis starting at a dose of 0.1% of the test substance.
48 h after the injections with 0.01% of the test substance all 4 animals showed slight erythema. At a concentration of 0.03% in 2 animals an apparent erythema was observed and in 2 animals an apparent erythema with oedema, whereas 1 animal showed an apparent erythema and 3 animals an apparent erythema with oedema after treatment with 0.05% of the test substance.
All 4 animals showed eschar formation or necrosis starting at a dose of 0.1% of the test substance.
72 h after the injections with 0.01% of the test substance all 4 animals showed slight erythema. At a concentration of 0.03% in 1 animal slight erythema was observed, in 1 animal an apparent erythema and the other 2 animals an apparent erythema with oedema, whereas 1 animal showed an apparent erythema and 3 animals an apparent erythema with oedema after treatment with 0.05% of the test substance.
All 4 animals showed eschar formation or necrosis starting at a dose of 0.1% of the test substance.
Epicutaneous application
4 female guinea pigs were treated per dose ( 0.3, 0.5, 1, 3, 5 and 10% test substance in ethanol (50% in water)). They and were checked for erythema and oedema after 3, 24 and 48 h after removal of the patch.
After 3 h, all 4 animals treated with the highest dose (10%) showed a very slight erythema which remained until 72 h after patch removal.
No erythema or oedema was detected in any other animal at any time point and using any other concentration (0.3 – 5%).
Body weight
The body weight gain of the the animals was not affected adversely during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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