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EC number: 700-936-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-04-04 to 2013-07-05
- 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:
- Reactive Golden Yellow HF-RN 1331
- IUPAC Name:
- Reactive Golden Yellow HF-RN 1331
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Reactive Golden Yellow HF-RN 1331
Batch No.: Kilo 10&12
Chemical Name: 4-[[2-[(Aminocarbonyl)amino]-4-[(2,6-difluoro-4 pyrimidinyl)-amino]phenyl]azo]-1,3-benzenedisulfonic acid, sodium salt
Formula: C17H11F2N7Na2O7S2
Physical State: solid (powder)
Colour: reddish orange
pH: 4.5 at 5%
Molecular Weight: 573.42 g/mol
Purity: 100 % (composition see AZ. No. 12-1327/2473 v.2, dated 2012-10-08)
Storage Conditions: room temperature
Expiry Date: 17.01.2014
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- - Full barrier in an air-conditioned room
-Temperature: 22 ± 3 °C
-Relative humidity: 55 ± 10%
-Artificial light, sequence being 12 hours light, 12 hours dark
-Air change: at least 10 x / hour
-Free access to Altromin 1324 maintenance diet for rats and mice (prescreen test and main study: lot no. 0902)
-Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control,
microbiological controls at regular intervals)
-The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding
(prescreen test: lot no. 011012, main study: lot no. 240113)
-Certificates of food, water and bedding are filed at BSL BIOSERVICE
-Adequate acclimatisation period (at least five days) under laboratory conditions
Study design: in vivo (LLNA)
- Vehicle:
- other: 2% carboxymethylcellulose (CMC) in aqua ad injectionem
- Concentration:
- Based on the results observed in the prescreen test the following test item concentrations were selected for the main study:
3%, 6% and 12.5% (w/v) - No. of animals per dose:
- 5 animals/dose group, 5 animals/control group
- Details on study design:
- Prescreen Test
Before the initiation of the prescreen test, a solubility test was performed to define the vehicle and the maximum concentration which is technically applicable to the animals.
The maximum technically applicable concentration of the test item in the vehicle was found to be 12.5% in 2% CMC in aqua ad injectionem.
In order to determine the highest tolerated and not excessively irritant test concentration a prescreen test was performed which was conducted
under the same conditions as the main study, except there was no assessment of lymph node proliferation. The mice were observed daily for any
clinical signs of systemic toxicity or local irritation at the application site. Body weights were recorded pre-test and prior to termination.
Both ears were observed for erythema and scored. Ear thickness measurements were performed on day 1 (pre-dose),
day 3 (approximately 48 hours after the first dose) and day 6. Excessive local irritation was indicated by an erythema score ≥ 3 and/or ear
swelling of ≥ 25%.
Two animals were treated by topical application with the test item on three consecutive days at a concentration of 12.5% (dissolved in 2% CMC)
to the entire dorsal surface of each ear.
One further animal was treated with 100% CMC (undiluted) and served as negative control.
Immediately before the first application, approximately 48 hours after the first application and shortly before sacrificing the thickness of both ears of all animals was measured.
During this period also all clinical signs were recorded.
Cageside observations included spontaneous activity, lethargy, recumbent position, convulsions, tremors, apnoea, asphyxia, vocalisation, diarrhoea, changes in the skin and fur, eyes and mucous membranes (salivation, discharge).
Neither signs of systemic toxicity nor signs of irritation at the application site could be detected in any animal.
All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the duration of the prescreen test.
Main Study
Preparation of the Animals
The animals were randomly selected.
Identification was ensured by cage number and individual marking (tail).
Clinical Observation
Prior to the application and once a day thereafter all animals were observed in order to detect signs of toxicity, including dermal irritation at site of application.
Weight Assessment
The animals were weighed prior to the application and at the end of the test period (prior to the treatment with 3HTdR).
Dose Groups
3 test groups (3 different concentrations) and 1 negative control group (vehicle) were tested.
Test Regime
Topical Application
Immediately before the first application the thickness of both ears of all animals was measured. Each mouse was treated by topical application of 25 µL of the selected solution to the entire dorsal surface of each ear. A second measurement of the ear thickness of all animals was carried out approximately 48 hours after the first application.
Topical applications were performed once daily over three consecutive days.
Administration of 3H-Methyl Thymidine
Five days after the first topical application all mice were dosed with 20 µCi 3H-methyl thymidine by intravenous injection (tail vein) of
250 µL of 3H-methyl thymidine, diluted to a working concentration of 80 µCi/mL.
Preparation of Cell Suspension
Approximately 5 hours after the injection of 3H-methyl thymidine all mice were sacrificed by cervical dislocation. Shortly before sacrificing
the thickness of the ears of all animals was measured for a third time. The draining auricular lymph nodes were excised, individually pooled
for each animal (2 lymph nodes per animal) and collected in phosphate buffered saline (PBS). A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamide gauze (200 mesh size). After washing the gauze with PBS the cell
suspension was pelleted in a centrifuge. The supernatant was discarded and the pellets were resuspended with PBS. This washing procedure
was repeated.
After the final wash each pellet was resuspended in approx. 1 mL 5% TCA at approx. 4° C for approximately 18 hours for precipitation of
macromolecules. Each precipitate was once washed again, resuspended in 1 mL 5% TCA and 7 mL scintillation fluid was added. Then this solution was transferred into scintillation vials and stored at room temperature overnight.
Determination of Incorporated 3H-Methyl Thymidine
The 3H-methyl thymidine – incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM).
Similarly, background 3H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was performed individually
for each animal.
Evaluation of Results
The proliferative response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node
(DPM/NODE) and as the ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group animals relative to that recorded for
control group animals (STIMULATION INDEX). Before DPM/NODE values were determined, background values were subtracted.
EC3 values, calculated concentrations which induce stimulation indices of three, are determined by linear interpolation
{EC3=c+[(3-d)/(b-d)]x(a c)}, between two points of the stimulation indices axis, one above (a,b) and one below (c,d) the
stimulation index of three. If all measured points are above or below the stimulation index of three, no EC3 value can be stated.
A substance is regarded as a 'sensitiser' in the LLNA if at least one concentration of the test item results in a 3-fold or greater increase in
3H-methyl thymidine - incorporation into lymph node cells of the test group animals, relative to that recorded for the lymph nodes of
control group animals (Stimulation Index equal to or greater than - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Outlier tests according to Dixon, Grubbs and Nalimov were performed for the values measured for the number of disintegrations per minute (DPM). If outliers were identified, these values were not included in the calculation of the stimulation indices. As at least four values per group are required for the evaluation of the results, the outlier test was not repeated to detect further outliers.
Results and discussion
- Positive control results:
- One of the three tested concentrations exceeded the stimulation index of 3.
The stimulation index at a concentration of 3% was 2.1
The stimulation index at a concentration of 6% was 2.3
The stimulation index at a concentration of 12.5% was 6.1
The stimulation index of the positive control (25% α-Hexylcinnamaldehyde in 2% CMC in aqua ad injectionem) was 9.1 and therefore the test
is considered to be valid.
All animals survived throughout the test period without showing any clinical signs.
Body Weight Development
All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study.
Measurement of Ear Thickness
Directly prior to the first application, approximately 48 hours after the first application and shortly before excising the lymph nodes the thickness of both ears from all animals was measured.
The means of the ear thickness per group showed no relevant difference compared to the negative control.
The mean ear thickness on day 1 day 3 day 6
for the 3% test group was 0.20 mm 0.20 mm 0.19 mm
for the 6% test group was 0.19 mm 0.20 mm 0.19 mm
for the 12.5% test group was 0.19 mm 0.20 mm 0.20 mm
for the negative control group was 0.19 mm 0.19 mm 0.19 mm
for the positive control group was 0.19 mm 0.21 mm 0.21 mm
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- One of the three tested concentrations exceeded the stimulation index of 3. The stimulation index at a concentration of 3% was 2.1 The stimulation index at a concentration of 6% was 2.3 The stimulation index at a concentration of 12.5% was 6.1 The stimulation index of the positive control (25% α-Hexylcinnamaldehyde in 2% CMC in aqua ad injectionem) was 9.1 and therefore the test is considered to be valid.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Animal number DPM DPM- mean back- ground 16 1187.0 1166.0 583.0 17 1670.0 1649.0 824.5 18 659.0 638.0 319.0 19 523.0 502.0 251.0 20 651.0 630.0 315.0 MV 938.0 917.0 458.5 SD 431.3 431.3 215.7 21 7557.0 7536.0 3768.0 22 5424.0 5403.0 2701.5 23 10658.0 10637.0 5318.5 24 11852.0 11831.0 5915.5 25 6354.0 6333.0 3166.5 MV 8369.0 8348.0 4174.0 SD 2480.5 2480.5 1240.2 1 2670.0 2649.0 1324.5 2 5315.0* n.d. n.d. 3 1527.0 1506.0 753.0 4 1859.0 1838.0 919.0 5 1597.0 1576.0 788.0 MV 1913.3 1892.3 946.1 SD 454.1 454.1 227.0 6 579.0 558.0 279.0 7 3918.0 3897.0 1948.5 8 3609.0 3588.0 1794.0 9 1610.0 1589.0 794.5 10 1094.0 1073.0 536.5 MV 2162.0 2141.0 1070.5 SD 1351.2 1351.2 675.6 11 2395.0 2374.0 1187.0 12 5570.0 5549.0 2774.5 13 4306.0 4285.0 2142.5 14 6848.0 6827.0 3413.5 15 9099.0 9078.0 4539.0 MV 5643.6 5622.6 2811.3 SD 2268.8 2268.8 1134.4 22.0 18.0 24.0 19.0 22.0 MV 21.0 0.0 0.0 SD 2.2 * = outlier, failed Grubbs, Nalimov and Dixon; n.d. = not determined
Any other information on results incl. tables
Table Ear Thickness – Preliminary Test (mm)
Animal No. | Measurement of Ear Thickness (mm) | ||||||
Concentration | Day 1 | Day 3 | Day 6 | ||||
left | right | left | right | left | right | ||
Reactive Golden Yellow HF-RN 1331 12.5% in CMC (2%) |
1 | 0.17 | 0.17 | 0.18 | 0.17 | 0.18 | 0.18 |
Reactive Golden Yellow HF-RN 1331 12.5% in CMC (2%) |
2 | 0.18 | 0.17 | 0.18 | 0.17 | 0.17 | 0.17 |
Negative Control 100% CMC (2%) |
3 | 0.18 | 0.18 | 0.17 | 0.17 | 0.17 | 0.17 |
Table Absolute Body Weights – Preliminary Test (g)
Concentration | Animal No. |
Start of Study |
End of Study |
Weight Gain |
Reactive Golden Yellow HF-RN 1331 12.5% in CMC (2%) |
1 | 23 | 23 | 0 |
Reactive Golden Yellow HF-RN 1331 12.5% in CMC (2%) |
2 | 22 | 21 | -1 |
Negative Control 100% CMC (2%) |
3 | 22 | 23 | 1 |
Table Radioactive Determination of the Test Substance and Control Groups
POS | CPM | Test Item | Conc. [%] | Animal number | DPM | DPM- mean back- ground | DPM/ Node | Stimu-lation Index | ||
56 | 571.0 | Negative | 100 | 16 | 1187.0 | 1166.0 | 583.0 | |||
57 | 805.0 | Control | 17 | 1670.0 | 1649.0 | 824.5 | ||||
58 | 319.0 | CMC (2 %) | 18 | 659.0 | 638.0 | 319.0 | ||||
59 | 253.0 | 19 | 523.0 | 502.0 | 251.0 | |||||
60 | 311.0 | 20 | 651.0 | 630.0 | 315.0 | |||||
MV | 451.8 | MV | 938.0 | 917.0 | 458.5 | 1.0 | ||||
SD | 207.8 | SD | 431.3 | 431.3 | 215.7 | |||||
61 | 3649.0 | Positive | 25 | 21 | 7557.0 | 7536.0 | 3768.0 | 8.2 | ||
62 | 2545.0 | Control | 22 | 5424.0 | 5403.0 | 2701.5 | 5.9 | |||
63 | 5105.0 | α-Hexylcinnamaldehyde | 23 | 10658.0 | 10637.0 | 5318.5 | 11.6 | |||
64 | 5652.0 | in CMC (2 %) | 24 | 11852.0 | 11831.0 | 5915.5 | 12.9 | |||
65 | 3066.0 | 25 | 6354.0 | 6333.0 | 3166.5 | 6.9 | ||||
MV | 4003.4 | MV | 8369.0 | 8348.0 | 4174.0 | 9.1 | ||||
SD | 1188.5 | SD | 2480.5 | 2480.5 | 1240.2 | 2.7 | ||||
66 | 1244.0 | Reactive Golden | 3 | 1 | 2670.0 | 2649.0 | 1324.5 | 2.9 | ||
67 | 2566.0* | Yellow HF-RN 1331 | 2 | 5315.0* | n.d. | n.d. | n.d. | |||
68 | 733.0 | in CMC (2 %) | 3 | 1527.0 | 1506.0 | 753.0 | 1.6 | |||
69 | 894.0 | 4 | 1859.0 | 1838.0 | 919.0 | 2.0 | ||||
70 | 768.0 | 5 | 1597.0 | 1576.0 | 788.0 | 1.7 | ||||
MV | 909.8 | MV | 1913.3 | 1892.3 | 946.1 | 2.1 | ||||
SD | 202.1 | SD | 454.1 | 454.1 | 227.0 | 0.5 | ||||
71 | 281.0 | Reactive Golden | 6 | 6 | 579.0 | 558.0 | 279.0 | 0.6 | ||
72 | 1873.0 | Yellow HF-RN 1331 | 7 | 3918.0 | 3897.0 | 1948.5 | 4.2 | |||
73 | 1757.0 | in CMC (2 %) | 8 | 3609.0 | 3588.0 | 1794.0 | 3.9 | |||
74 | 775.0 | 9 | 1610.0 | 1589.0 | 794.5 | 1.7 | ||||
75 | 529.0 | 10 | 1094.0 | 1073.0 | 536.5 | 1.2 | ||||
MV | 1043.0 | MV | 2162.0 | 2141.0 | 1070.5 | 2.3 | ||||
SD | 650.4 | SD | 1351.2 | 1351.2 | 675.6 | 1.5 | ||||
76 | 1148.0 | Reactive Golden | 12.5 | 11 | 2395.0 | 2374.0 | 1187.0 | 2.6 | ||
77 | 2683.0 | Yellow HF-RN 1331 | 12 | 5570.0 | 5549.0 | 2774.5 | 6.1 | |||
78 | 2042.0 | in CMC (2 %) | 13 | 4306.0 | 4285.0 | 2142.5 | 4.7 | |||
79 | 3302.0 | 14 | 6848.0 | 6827.0 | 3413.5 | 7.4 | ||||
80 | 4367.0 | 15 | 9099.0 | 9078.0 | 4539.0 | 9.9 | ||||
MV | 2708.4 | MV | 5643.6 | 5622.6 | 2811.3 | 6.1 | ||||
SD | 1093.9 | SD | 2268.8 | 2268.8 | 1134.4 | 2.5 | ||||
81 | 11.0 | Background | 22.0 | |||||||
82 | 9.0 | Szinti and | 18.0 | |||||||
83 | 12.0 | TCA | 24.0 | |||||||
84 | 9.0 | 19.0 | ||||||||
85 | 11.0 | 22.0 | ||||||||
MV | 10.4 | MV | 21.0 | 0.0 | 0.0 | 0.0 | ||||
SD | 1.2 | SD | 2.2 | |||||||
* = outlier, failed Grubbs, Nalimov and Dixon; n.d. = not determined |
Table Absolute Body Weights in g
Concentration | Animal No. |
Start of Study |
End of Study |
Weight Gain |
1 | 21 | 22 | 1 | |
Reactive Golden | 2 | 22 | 23 | 1 |
Yellow HF-RN 1331 | 3 | 19 | 20 | 1 |
3 % in CMC (2%) | 4 | 19 | 21 | 2 |
5 | 18 | 21 | 3 | |
6 | 21 | 21 | 0 | |
Reactive Golden | 7 | 19 | 20 | 1 |
Yellow HF-RN 1331 | 8 | 21 | 22 | 1 |
6 % in CMC (2%) | 9 | 21 | 23 | 2 |
10 | 20 | 21 | 1 | |
11 | 19 | 21 | 2 | |
Reactive Golden | 12 | 18 | 20 | 2 |
Yellow HF-RN 1331 | 13 | 20 | 23 | 3 |
12.5 % in CMC (2%) | 14 | 21 | 23 | 2 |
15 | 20 | 21 | 1 | |
16 | 20 | 22 | 2 | |
Negative Control | 17 | 19 | 20 | 1 |
100% CMC (2%) | 18 | 20 | 22 | 2 |
19 | 18 | 21 | 3 | |
20 | 21 | 23 | 2 | |
Positive Control 25% α-Hexyl- cinnamaldehyde in CMC (2%) |
21 | 22 | 23 | 1 |
22 | 19 | 21 | 2 | |
23 | 21 | 22 | 1 | |
24 | 20 | 20 | 0 | |
25 | 19 | 20 | 1 |
Table Clinical Observation
Time of Observation |
Systemic Effects |
Local Effects |
Group 1, animals no. 1 – 5 / test item at a concentration of 3% inin CMC (2%) |
||
Day 1 |
nsf |
nsf |
Day2 |
nsf |
nsf |
Day3 |
nsf |
nsf |
Day4 |
nsf |
nsf |
Day5 |
nsf |
nsf |
Day6 |
nsf |
nsf |
Group 2, animals no. 6 – 10 / test item at a concentration of 6%in CMC (2%) |
||
Day 1 |
nsf |
nsf |
Day2 |
nsf |
nsf |
Day3 |
nsf |
nsf |
Day4 |
nsf |
nsf |
Day5 |
nsf |
nsf |
Day6 |
nsf |
nsf |
Group 3, animals no. 11 – 15 / test item at a concentration of 12.5%in CMC (2%) |
||
Day 1 |
nsf |
nsf |
Day2 |
nsf |
nsf |
Day3 |
nsf |
nsf |
Day4 |
nsf |
nsf |
Day5 |
nsf |
nsf |
Day6 |
nsf |
nsf |
Group 4, animals no. 16 – 20 / negative control100% CMC (2%) |
||
Day 1 |
nsf |
nsf |
Day2 |
nsf |
nsf |
Day3 |
nsf |
nsf |
Day4 |
nsf |
nsf |
Day5 |
nsf |
nsf |
Day6 |
nsf |
nsf |
Group 5, animals no. 21 – 25 / positive control 25%in CMC (2%) |
||
Day 1 |
nsf |
nsf |
Day2 |
nsf |
nsf |
Day3 |
nsf |
nsf |
Day4 |
nsf |
nsf |
Day5 |
nsf |
nsf |
Day6 |
nsf |
nsf |
nsf = no specific findings
Applicant's summary and conclusion
- Conclusions:
- The most conservative EC3 value (= estimated concentration needed to produce a stimulation index of 3, derived by linear interpolation) was
calculated to be at a test item of 7.14%.
Under the conditions of this study the test item Reactive Golden Yellow HF-RN 1331 was found to be a skin sensitizer.
The measurement of the ear thickness did not reveal any relevant increase of the ear thickness in any dosage group. - Executive summary:
Based on the results of the prescreen test the test item was assessed for sensitising properties at concentrations of 3%, 6% and 12.5% (w/v), each diluted with 2% carboxymethylcellulose (CMC) inaqua ad injectionem. The concentration of 12.5% in 2% CMC in aqua ad injectionem was the maximum technically applicable concentration of the test item in the vehicle.
At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed.Species/strain: Mice, CBA/CaOlaHsd
Number of animals: 25/main test, 3/prescreen test
Vehicle: 2% carboxymethylcellulose (CMC) inaqua ad injectionem.
Summary Results
One of the three tested concentrations exceeded the stimulation index of 3.
The stimulation index at a concentration of 3% was 2.1
The stimulation index at a concentration of 6% was 2.3
The stimulation index at a concentration of 12.5% was 6.1
The mean ear thickness on
day 1
day 3
day 6
for the 3% test group was
0.20 mm
0.20 mm
0.19 mm
for the 6% test group was
0.19 mm
0.20 mm
0.19 mm
for the 12.5% test group was
0.19 mm
0.20 mm
0.20 mm
for the negative control group was
0.19 mm
0.19 mm
0.19 mm
for the positive control group was
0.19 mm
0.21 mm
0.21 mm
The stimulation index of the positive control (25% α-Hexylcinnamaldehyde in2% CMC in aqua ad injectionem) was 9.1 and therefore the test is considered to be valid.
Conclusion
The most conservative EC3 value (= estimated concentration needed to produce a stimulation index of 3, derived by linear interpolation) was calculated to be at a test item of 7.14%.
Under the conditions of this study the test item Reactive Golden Yellow HF-RN 1331 was found to be a skin sensitizer.
The measurement of the ear thickness did not reveal any relevant increase of the ear thickness in any dosage group.
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