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EC number: 939-582-4 | CAS number: 1471315-26-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 Dec 2012 - 11 Jan 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), aluminum salts
- EC Number:
- 939-582-4
- Cas Number:
- 1471315-26-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), aluminum salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, tallow, hydrogenated, aluminium salts
- Physical state: white solid powder
- Analytical purity: 84.33%
- Impurities (identity and concentrations): ash content 9.17%; humidity 0.75%; free fatty acids 14.13%; water-soluble salts 0.61%; aluminium 4.13%
- Purity test date: 2012-05-04
- Lot/batch No.: C200752-001
- Expiration date of the lot/batch: 2014-02-14
- Storage conditions: at room temperature
- Other: CAS 91770-05-7
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsD
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 17 - 23 g
- Housing: 5 animals per cage in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding (lot No. 160812)
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum (lot No. 0636)
- Water: tap water, sulphur acidified to a pH value of approx. 2.8, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 6.25, 12.5 and 25% (w/v)
- No. of animals per dose:
- 5 (main study), 3 (pre-screen test including 2 test and 1 control animal)
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A maximum technically achievable concentration of 25% (w/v) test substance dissolved in AOO was determined in the solubility test.
- Irritation:
2 mice were treated by topical application with 25% test item solution on 3 consecutive days. 1 animal treated with the vehicle AOO served as negative control. All animals were observed daily for any clinical signs of systemic toxicity or local irritation at the application site. Body weights were recorded prior to the first treatment and prior to termination. Both ears of each mouse were observed for erythema/eschar formation and scored. Measurement of ear thickness was performed on Day 1 (pre-dose), Day 3 (approximately 48 h after the first dose) and Day 6.
No mortality or any signs of systemic toxicity were observed. No significant signs of irritation were observed as indicated by an erythema score ≥ 3 and/or an increased ear thickness of ≥ 25% on any day of measurement (25%: 0.19 mm (mean value of 2 animals over day 1, 3 and 6); vehicle: 0.18 mm (mean value of 1 animal over day 1, 3 and 6)). According to this, the maximum technically applicable concentration of 25 % (w/v) was selected as the highest test concentration in the main test.
- Lymph node proliferation response: Lymph node proliferation was not assessed in the range-finding test.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by ß-scintillation
- Criteria used to consider a positive response: The test item was considered as a skin sensitizer, if exposure to at least one concentration of the test item resulted in an at least 3-fold or greater stimulation index in test animals compared to control mice (SI ≥ 3).
- Validation criteria: The positive control substance phenylenediamine (1%) should produce a positive LLNA response shown by a SI > 3 over the negative control group without causing excessive skin irritation (i.e. SI > 20) or systemic toxicity.
TREATMENT PREPARATION AND ADMINISTRATION:
25 µL of the test item was applied on the entire dorsal surface of each ear for each concentration. The application was repeated once daily over 3 consecutive days. Local irritation reactions were assessed and ear thickness measurements were performed prior to the first treatment, on Day 3 and 6. On Day 6, an injection of 250 µL phosphate buffered saline containing 20 µCi of 3H-methyl thymidine was made into the tail vein of each experimental mouse. Approx. 5 h later, animals were sacrificed and the draining auricular lymph node of each ear was excised. Each lymph node was weight before a single cell suspension of lymph node cells, individually pooled for each animal, was prepared. After repeated washings, pooled lymphe node cells were precipitated with 5% trichloracetic acid at 4 °C overnight. The 3H-methyl thymidine-incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM) individually for each animal.
CLINICAL OBSERVATIONS:
All animals were observed prior to the application and once a day thereafter to detect signs of toxicity. Irritation at the site of application was monitored by erythema scoring according to the scale defined in OECD GL 429 and recorded for each animal individually. Body weights were recorded prior to substance application and prior to 3H-methyl thymidine injection. - Positive control substance(s):
- other: phenylenediamine (1% in AOO)
Results and discussion
- Positive control results:
- The positive control substance induced a significant lymphoproliferative response as shown by a stimulation index value of 7.3.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- No significant (SI ≥ 3) lymphoproliferative response was noted for the test substance at the tested concentrations. The calculated stimulation index values were 1.2, 1.1 and 0.9 at test item concentrations of 6.25%, 12.5% and 25%, respectively. Lymphe node weights of test animals were slightly increased compared to control values but lay within the standard deviation received for control animals (please refer to table 1).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- No significant or dose-dependent increase in the DPM values was observed in the test groups compared to the controls (675.6 ± 100, 812.6 ± 119, 741.7 ± 61 and 636.9 ± 284 for the DPM/lymph node value of control, low- mid- and high- dose animals, respectively.
Any other information on results incl. tables
No significant effects on body weight were observed in any treatment group. All animals showed the expected weight development including a weight loss of up to 1 g throughout the study.
Further, no mortality or symptoms of systemic toxicity were observed.
No signs of dermal irritation were noted at the application site in all test animals (please refer to table 2 for details).
Table 1: Lymph node weights after topical administration
Group |
Left lymph node weight (mg) |
Right lymph node weight (mg) |
Mean weight / animal |
Mean weight / group |
Vehicle control (100% AOO) |
3.5 |
2.0 |
2.8 |
2.54 ± 0.33 |
2.2 |
2.3 |
2.3 |
||
2.1 |
2.5 |
2.3 |
||
2.4 |
2.2 |
2.3 |
||
3.1 |
2.8 |
3.0 |
||
6.25% |
3.1 |
2.3 |
2.7 |
2.72 ± 0.15 |
2.9 |
2.1 |
2.5 |
||
2.6 |
2.8 |
2.7 |
||
3.0 |
2.6 |
2.8 |
||
1.5 |
4.3 |
2.9 |
||
12.5% |
2.0 |
2.7 |
2.4 |
2.74 ± 0.3 |
3.1 |
3.2 |
3.2 |
||
2.7 |
2.5 |
2.6 |
||
3.1 |
2.5 |
2.8 |
||
2.6 |
2.8 |
2.7 |
||
25% |
2.6 |
2.2 |
2.4 |
2.78 ± 0.3 |
3.6 |
2.4 |
3.0 |
||
3.1 |
2.6 |
2.9 |
||
3.5 |
2.7 |
3.1 |
||
2.1 |
2.8 |
2.5 |
Table 2: Ear thickness measurements after topical administration
Group |
Measurement of ear thickness (mm) |
|||||
|
Day 1 |
Day 3 |
Day 6 |
|||
|
left |
right |
left |
right |
left |
right |
Vehicle control (100% AOO) |
0.17 |
0.18 |
0.17 |
0.17 |
0.18 |
0.18 |
0.17 |
0.18 |
0.17 |
0.17 |
0.17 |
0.16 |
|
0.19 |
0.18 |
0.18 |
0.18 |
0.19 |
0.18 |
|
0.18 |
0.19 |
0.19 |
0.19 |
0.20 |
0.20 |
|
0.19 |
0.19 |
0.19 |
0.20 |
0.19 |
0.18 |
|
Mean |
0.18 ± 0.01 |
0.18 ± 0.01 |
0.18 ± 0.01 |
|||
6.25% |
0.18 |
0.18 |
0.17 |
0.18 |
0.20 |
0.20 |
0.18 |
0.18 |
0.19 |
0.19 |
0.19 |
0.19 |
|
0.19 |
0.19 |
0.18 |
0.18 |
0.19 |
0.20 |
|
0.20 |
0.19 |
0.18 |
0.18 |
0.20 |
0.19 |
|
0.18 |
0.19 |
0.19 |
0.20 |
0.19 |
0.18 |
|
Mean |
0.19 ± 0.01 |
0.18 ± 0.01 |
0.19 ± 0.01 |
|||
12.5% |
0.18 |
0.19 |
0.18 |
0.19 |
0.20 |
0.20 |
0.18 |
0.17 |
0.18 |
0.18 |
0.21 |
0.20 |
|
0.18 |
0.18 |
0.19 |
0.19 |
0.20 |
0.19 |
|
0.17 |
0.17 |
0.18 |
0.19 |
0.19 |
0.19 |
|
0.19 |
0.19 |
0.18 |
0.19 |
0.19 |
0.19 |
|
Mean |
0.18 ± 0.01 |
0.19 ± 0.01 |
0.20 ± 0.01 |
|||
25% |
0.18 |
0.17 |
0.19 |
0.18 |
0.20 |
0.20 |
0.17 |
0.19 |
0.18 |
0.19 |
0.18 |
0.19 |
|
0.18 |
0.19 |
0.19 |
0.20 |
0.20 |
0.19 |
|
0.18 |
0.18 |
0.20 |
0.19 |
0.20 |
0.18 |
|
0.18 |
0.20 |
0.18 |
0.17 |
0.19 |
0.19 |
|
Mean |
0.18 ± 0.01 |
0.19 ± 0.01 |
0.19 ± 0.01 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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