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EC number: 268-938-5 | CAS number: 68155-09-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep 1996 - Oct 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Jul 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No justification given.
Test material
- Reference substance name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- EC Number:
- 268-938-5
- EC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- Cas Number:
- 68155-09-9
- Molecular formula:
- Unspecified
- IUPAC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: TH Goldschmidt AG, Essen, Germany
- Batch No.of test material: 571003
- Active component: 35%
- Physical state: clear, viscous liquid
- Density: approx. 1.00 g/ml
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient
- Stability under test conditions: March 1997
OTHER SPECIFICS:
- Solvent/vehicle: intradermal injection and dermal application: aqua ad iniect.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Remarks:
- white. Substrain: Hsd/Poc: DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, 33178 Borchen, Germany
- Date of receipt: August 7, 1996 (range finding); September 18, 1996 (main test)
- Weight at study initiation: male 308 - 349 g, female 295 - 339 g (main test)
- Housing: collective housing up to a maximum of 10 animals per cage
- Diet: ad libitum, Ssniff-G (Ssniff Spezialdiäten GmBh, Soest, Germany)
- Water: ad libitum
- Acclimation period: 35 days (range finding), 8 days (main test)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 (illumination from 7 am to 7 pm)
- Measurement: twice daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 2.5%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50%
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals used for the test substance and 10 control animals
- Details on study design:
- RANGE FINDING TESTS:
A. INTRADERMAL INJECTION
- Concentration: 5%, dilution with aqua ad iniect. and Freund's complete adjuvant (FCA). Since this concentration produced immoderate irritation such as grey-black discoloration, lower concenrations were tested.
- 4 animals were employed and skin reactions were recorded 48 h post application
B. DERMAL APPLICATION
- the test article was used undiluted. Since the maximum concentration was irritating, lower concentrations were tested.
- occlusive bandage was used
- 10 animals were employed and skin reactions were recorded 48 h post application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epicutaneous
- Exposure period: - (id), 48 hours (epic)
- Test groups: Test subsstance, Test substance + FCA, FCA (id); Test substance (epic.)
- Control group: FCA, water+FCA, water (id); water (epic.)
- Site: shoulder
- Frequency of applications: 0 (id), 7d (epic.)
- Duration: 0-7d
- Concentrations: 2.5% (id), 50% (epic.)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14d
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left flank test substance, right flank water
- Concentrations: 5%
- Evaluation (hr after challenge): 24, 48 h
- Challenge controls:
- Control animals were treated with the test substance concurrently with the test groups in the challenge phase.
- Positive control substance(s):
- no
- Remarks:
- The reaction to the positive control substance (benzocaine) is tested periodically. The last test was performed in June 1996.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- Skin reactions were observed
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- Skin reactions were observed
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Skin reactions were observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Skin reactions were observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1: Challenge exposure in the test group - results
|
24h |
|
|||||
Animal |
|
Initial |
Test |
|
Test |
|
Final |
no. |
Sex |
BW(g) |
article E Oe |
Vehicle E Oe |
article E Oe |
Vehicle E Oe |
BW(g) |
1 |
m |
321 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
489 |
2 |
m |
343 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
580 |
3 |
m |
349 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
543 |
4 |
m |
316 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
490 |
5 |
m |
317 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
517 |
6 |
m |
320 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
532 |
7 |
m |
326 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
476 |
8 |
m |
329 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
516 |
9 |
m |
308 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
484 |
10 |
m |
322 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
489 |
11 |
f |
303 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
441 |
12 |
f |
337 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
518 |
13 |
f |
295 |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
411 |
14 |
f |
323 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
459 |
15 |
f |
314 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
468 |
16 |
f |
326 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
485 |
17 |
f |
322 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
480 |
18 |
f |
313 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
446 |
19 |
f |
318 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
436 |
20 |
f |
305 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
430 |
Reaction rate at 24 h: 60%
Sensitization rate at 24 h: 20%
Reaction rate at 48 h: 65%
Sensitization rate at 48 h: 15%
Severity index:
test article (leftflank):
mean value (E) 24 h: 0.80
mean value (Oe) 24 h: 0.05
mean value (E) 48 h: 0.80
mean value (Oe) 48 h: 0.05
Severity index: vehicle (rightflank):
mean value(E)24 h: 0.00
mean value (Oe) 24 h: 0.00
mean value(E)48 h: 0.00
mean value (Oe) 48 h: 0.00
m=male; f=female; BW=body weight; E=erythema; Oe=oedema
Table 2: Challenge exposure in the control group - results
Animal no. |
Initial SexBW(g) |
24hTest article E Oe |
Vehicle E Oe |
48hTest article E Oe |
Vehicle E Oe |
Final BW(g) |
|||||
1 |
m |
324 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
522 |
2 |
m |
320 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
518 |
3 |
m |
317 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
471 |
4 |
m |
314 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
484 |
5 |
m |
310 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
468 |
6 |
f |
303 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
509 |
7 |
f |
339 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
511 |
8 |
f |
317 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
508 |
9 |
f |
327 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
500 |
l0 |
f |
315 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
525 |
Table 2.2.: Results belonging to results presented in table 2
Reaction rate at 24 h:
Severity index: test article (leftflank): |
20% |
Reaction rate at 48 h:
Severity index: vehicle (rightflank): |
20% |
mean value (E) 24 h: |
0.20 |
mean value(E)24 h: |
0.00 |
mean value (Oe) 24 h: |
0.00 |
mean value (Oe) 24 h: |
0.00 |
mean value(E)48 h: |
0.20 |
mean value(E)48 h: |
0.00 |
mean value (Oe) 48 h: |
0.00 |
mean value (Oe) 48 h: |
0.00 |
m=male; f=female; BW=bodyweight; E=erythema; Oe=oedema
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the maximization scheme of Magnusson and Kligman (1996), the test substance is classified as a mild sensitzier (The sensitization rate at 24 h was 20 % and at 48 h 15 %).
According to GHS, EU criteria the substance has not to be classfied as skin sensitizer. - Executive summary:
The potential skin sensitizing potential of the test substance was assessed in the guinea pig maximization test using 20 test and 10 control animals. Following induction exposure to the test substance or the vehicle, the animals were subjected to two weeks later to a challenge a challenge exposure with the test substance. The treated skin areas were evaluated 24 and 48 hours after the end of the exposure period. According to Magnusson and Kligman (J. Invest. Dermatol. 52, 268 -276, 1969), the test substance is classified as a "mild sensitizer".
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