Registration Dossier
Registration Dossier
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EC number: 941-981-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (purity: 76%)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Valid study report available before REACh came into force, therefore no new LLNA test was performed.
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
- EC Number:
- 941-981-3
- Molecular formula:
- not available, substance is UVCB
- IUPAC Name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, Massachusetts, USA
- Age at study initiation: young adults
- Weight at study initiation: 382 - 508 g
- Housing: group housed in suspended stainless steel caging
- Diet: Pelleted Purina Guinea Pig Chow #5025, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- - Induction: 100%
- Challenge: 75%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- - Induction: 100%
- Challenge: 75%
- No. of animals per dose:
- - Preliminary irritation group: 4
- Test group: 20
- Test naive control group: 10 - Details on study design:
- RANGE FINDING PRETEST
A group of animals was used to determine the highest non-irritating concentration (HNIC) of the test substance to establish the challenge dose. The fur was removed by clipping (Oster model #A5-small) the dorsal area and flanks of each guinea pig. This area was divided into four test sites (two sites on each side of the midline) on each animal. The test substance was applied neat (100%) and also diluted with mineral oil to yield concentrations of 75%, 50% and 25% w/w. Each concentration was applied to a test site using an occlusive 25 mm Hilltop Chamber. The sites were wrapped with non-allergenic Durapore adhesive tape. After 6 hours of exposure, the chambers were removed and the test sites were cleaned. Approximately 24 hours after application, each site was evaluated for local reactions (erythema). Based on the observed results, a concentration of 75% was defined as HINC used for challenge (in 4 guinea pigs, 2/4 animals showed local skin reactions scored with 0.5 and the remaining animals were free of local effects (score 0)).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h (after every exposure period the test sites were cleaned of residual test substance).
- Test groups: 20 animals, treated with test item
- Site: left side
- Frequency of applications: Once each week for three weeks.
- Duration: 3 weeks
- Concentrations: 100%
- Pretreatment: On the day before initiation, the fur of a group of animals was removed by clipping the dorsal area and flanks.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27 days after the first induction dose
- Exposure period: 24 h
- Test groups: 20 animals, treated with test item
- Control group: 10, treated with test item
- Site: naive site on the right side
- Concentrations: 75%
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- In addition to the test animals, 10 guinea pigs from the same shipment were maintained under identical environmental conditions and were treated with the HNIC of the test substance at challenge only. These animals constituted the "naive" group.
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde, technical grade (85% active ingredient)
Results and discussion
- Positive control results:
- periodically tested, last test with acceptable level of response: September 6, 2002
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: neat substance; challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Very faint erythema (score 0.5) were observed in 12/20 test animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: neat substance; challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Very faint erythema (score 0.5) were observed in 12/20 test animals..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Very faint erythema (score 0.5) were observed in 7/10 naive control animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Very faint erythema (score 0.5) were observed in 7/10 naive control animals..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: neat substance; challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: neat substance; challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenge: 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: challenge: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
Individual challenge readings:
Animal No. |
Hours after Dosing |
|
24 |
48 |
|
Test Group |
||
1 |
0 |
0 |
2 |
0.5 |
0 |
3 |
0 |
0 |
4 |
0 |
0 |
5 |
0.5 |
0 |
6 |
0.5 |
0 |
7 |
0 |
0 |
8 |
0.5 |
0 |
9 |
0 |
0 |
10 |
0.5 |
0 |
11 |
0.5 |
0 |
12 |
0.5 |
0 |
13 |
0.5 |
0 |
14 |
0.5 |
0 |
15 |
0.5 |
0 |
16 |
0.5 |
0 |
17 |
0.5 |
0 |
18 |
0 |
0 |
19 |
0 |
0 |
20 |
0 |
0 |
Test Naive Control Group |
||
1 |
0.5 |
0 |
2 |
0.5 |
0 |
3 |
0.5 |
0 |
4 |
0.5 |
0 |
5 |
0 |
0 |
6 |
0.5 |
0 |
7 |
0 |
0 |
8 |
0 |
0 |
9 |
0.5 |
0 |
10 |
0.5 |
0 |
Historical Positive Control Validation Study |
||
Positive Control |
||
1 |
0.5 |
0.5 |
2 |
1 |
1 |
3 |
0.5 |
0.5 |
4 |
0.5 |
0 |
5 |
0.5 |
0.5 |
6 |
0.5 |
0.5 |
7 |
0.5 |
0.5 |
8 |
0.5 |
0 |
9 |
1 |
0.5 |
10 |
1 |
0.5 |
Naive Control |
||
1 |
0.5 |
0.5 |
2 |
0.5 |
0.5 |
3 |
0.5 |
0.5 |
4 |
0 |
0 |
5 |
0.5 |
0.5 |
After challenge with the test substance, the sensitisation rate at 24 h and 48 h was 0%.
No deaths occurred. No significant difference in body weight gain was observed between treated and control group.
Regarding the historical positive controls, the sensitisation rate at 24 h was 30% and at 48 h 10%. This result validates the test system used in this study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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