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Registration Dossier
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EC number: 221-178-8 | CAS number: 3025-30-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- March 8-April 20, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: JID 47: 393-409, 1966
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- A LLNA test was not performed as this in vivo study using humans was already available.
Test material
- Reference substance name:
- Ethyl (2E,4Z)-2,4-decadienoate
- EC Number:
- 221-178-8
- EC Name:
- Ethyl (2E,4Z)-2,4-decadienoate
- Cas Number:
- 3025-30-7
- Molecular formula:
- C12H20O2
- IUPAC Name:
- ethyl deca-2,4-dienoate
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: volunteers
ENVIRONMENTAL CONDITIONS
- IN-LIFE DATES: From: March 8, 1982 To: April 20, 1982
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 10 days
- Adequacy of induction:
- other: a pre-test showed the test substance showed no significant evidence of irritation, so test subjects were pretested with 3% SLS.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hrs
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 27 (Originally 30, but 3 volunteers did not complete the study.)
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 exposures for 48 hrs
- Exposure period: 10 days total
- Site: forearms
- Frequency of applications: every other day
- Duration: 48 hrs
B. CHALLENGE EXPOSURE
- No. of exposures: 27
- Day(s) of challenge: After a 10-14 day rest from the induction
- Exposure period: 48 hrs
- Control group: SLS and petrolatum were used as controls on the same volunteers
- Site: forearms
- Evaluation (hr after challenge): 48 hrs
OTHER: Prior to the induction, patch sites were pretreated with 5% SLS. For the challenge test, 5% SLS was applied 30 minutes prior to the challenge exposure on the left side, and no SLS was used on the right side. - Challenge controls:
- SLS and petrolatum were used as controls on the same volunteers.
- Positive control substance(s):
- yes
- Remarks:
- SLS
Results and discussion
- Positive control results:
- 5% SLS produced very little reactivity.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 27
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 27
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 27
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 27
Any other information on results incl. tables
Test Substance Challenge Results
| Subject No. | With SLS at 48 hrs | With SLS at 72 hrs | Without SLS at 48 hrs | Without SLS at 72 hrs |
| 1 | N | N | N | N |
| 2 | N | N | N | N |
| 3 | N | N | N | N |
| 4 | N | N | N | N |
| 5 | N | N | N | N |
| 6 | N | N | N | N |
| 7 | -- | -- | -- | -- |
| 8 | N | N | N | N |
| 9 | N | N | N | N |
| 10 | N | N | N | N |
| 11 | N | N | N | N |
| 12 | N | N | N | N |
| 13 | N | N | N | N |
| 14 | N | N | N | N |
| 15 | -- | -- | -- | -- |
| 16 | -- | -- | -- | -- |
| 17 | N | N | N | N |
| 18 | N | N | N | N |
| 19 | N | N | N | N |
| 20 | N | N | N | N |
| 21 | N | N | N | N |
| 22 | N | N | N | N |
| 23 | N | N | N | N |
| 24 | N | B | N | N |
| 25 | N | N | N | N |
| 26 | N | N | N | N |
| 27 | N | N | N | N |
| 28 | N | N | N | N |
| 29 | N | N | N | N |
| 30 | -- | -- | -- | -- |
Control Challenge Results
| Subject No. | With SLS at 48 hrs | With SLS at 72 hrs | Without SLS at 48 hrs | Without SLS at 72 hrs |
| 1 | N | N | N | N |
| 2 | N | N | N | N |
| 3 | N | N | N | N |
| 4 | N | N | N | N |
| 5 | N | N | N | N |
| 6 | N | N | N | N |
| 7 | -- | -- | -- | -- |
| 8 | N | N | N | N |
| 9 | N | N | N | N |
| 10 | N | N | N | N |
| 11 | N | N | N | N |
| 12 | N | N | N | N |
| 13 | N | N | N | N |
| 14 | N | N | N | N |
| 15 | -- | -- | -- | -- |
| 16 | -- | -- | -- | -- |
| 17 | N | N | N | N |
| 18 | N | N | N | N |
| 19 | N | N | N | N |
| 20 | N | N | N | N |
| 21 | N | N | N | N |
| 22 | N | N | N | N |
| 23 | N | N | N | N |
| 24 | N | B | N | N |
| 25 | N | N | N | N |
| 26 | N | N | N | N |
| 27 | N | N | N | N |
| 28 | N | N | N | N |
| 29 | N | N | N | N |
| 30 | -- | -- | -- | -- |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No significant irritant or allergic reactions were noted.
- Executive summary:
The skin sensitization of ethyl decadienoate was tested in a maximization test using 27 human volunteers. No volunteers showed significant reactions during the challenge phase. The test had significant methodoligical deficiencies, most notably, the test substance concentration and scoring system was not reported.
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