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EC number: 289-550-2 | CAS number: 89923-62-6
- 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
- EC Number:
- 289-550-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
- Cas Number:
- 89923-62-6
- Molecular formula:
- C23H19N3O6S.Na
- IUPAC Name:
- sodium 1-amino-9,10-dioxo-4-[(3-propanamidophenyl)amino]-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- other: Solid
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Identification: FAT 20242/1 TE
Batch: AT-PD14-026Al
Purity:91%
Physical state - Appearance: dark blue solid
Expiry date: 20 January 2019
Storage Conditions: room temperature in the dark
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Horst, The Netherlands.
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: The animals were housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK).
- Water (e.g. ad libitum): Free access to mains tap water.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give 12 hours continuous light (06.00 to 18.00) and 12 hours darkness.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Preliminary Screening Test: 25 µL of the test item at a concentration of 50% w/w in dimethyl formamide.
Main Test: 50%, 25% or 10% w/w in dimethyl formamide. - No. of animals per dose:
- Preliminary Screening Test: One mouse
Main Test: Four mice per group - Details on study design:
- Preliminary Screening Test
Using available information regarding the systemic toxicity of the test item, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µL of the test item at a concentration of 50% w/w in dimethyl formamide, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any clinical signs of toxicity, if present, were also recorded. The body weight was recorded on Day 1 (prior to dosing) and on Day 6.
The thickness of each ear was measured using a Mitutoyo 547 3008 gauge (Mitutoyo Corporation), pre dose on Day 1, post dose on Day 3 and on Day 6. Any changes in the ear thickness were noted. Mean ear thickness changes were calculated between time periods Days 1 and 3 and Days 1 and 6. A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitization.
Main Test
Test Item Administration
Groups of four mice were treated with the test item at concentrations of 50%, 25% or 10% w/w in dimethyl formamide. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
3H-Methyl Thymidine Administration
Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 3H methyl thymidine (3HTdR: 80 µCi/mL, specific activity 2.0 Ci/mmoL, ARC UK Ltd) giving a total of 20 µCi to each mouse.
Observations
Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
Body Weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
Terminal Procedures
Termination: Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes.
Preparation of Single Cell Suspension: A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200 mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish labelled with the study number and dose concentration. The lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm (approximately 190 g) for 10 minutes. The pellet was re suspended in 10 mL of PBS and re pelleted. To precipitate out the radioactive material, the pellet was re suspended in 3 mL of 5% Trichloroacetic acid (TCA).
Determination of 3HTdR Incorporation: After approximately 18 hours incubation at approximately 4 °C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for 10 minutes, re suspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid (Optiphase 'Trisafe'). 3HTdR incorporation was measured by β-scintillation counting. The "Poly Q™" vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left to stand in darkness for approximately 20 minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately 20 minutes, the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system (Beckman Instruments Inc, Fullerton, CA, USA). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No data
Results and discussion
- Positive control results:
- Methods
Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of α Hexylcinnamaldehyde, tech., 85% as a solution in dimethyl formamide at concentrations of 5%, 15% or 25% v/v. A further group of five animals was treated with dimethyl formamide alone and served as the vehicle control group.
Results
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
5 % v/v in dimethyl formamide gave a stimulation index of 2.1 (negative)
15 % v/v in dimethyl formamide gave a stimulation index of 6.26 (positive)*
25 % v/v in dimethyl formamide gave a stimulation index of 8.14 (positive)
*Based on four animals due to the death of one animal on Day 6
The concentration of α Hexylcinnamaldehyde, tech., 85% expected to cause a 3-fold increase in 3HTdR incorporation (EC3 value) was calculated to be 6%.
Conclusion
α Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10 %
- Remarks on result:
- other: Negative
- Parameter:
- SI
- Value:
- 1.23
- Test group / Remarks:
- 25 %
- Remarks on result:
- other: Negative
- Parameter:
- SI
- Value:
- 1.28
- Test group / Remarks:
- 50 %
- Remarks on result:
- other: Negative
Any other information on results incl. tables
Preliminary Screening Test
Blue colored staining of the ears and fur was noted post dose on Days 1 to 3 and on Days 4 to 6.
No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted.
Based on this information the dose levels selected for the main test were 50 %, 25 % and 10 % w/w in dimethyl formamide.
Main Test
Clinical Observations and Mortality Data
Blue colored staining of the ears and fur was noted, post dose on Days 1 to 3, in animals treated with the test item at concentrations of 50 % or 25 % w/w in dimethyl formamide.
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Body Weight
Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.
Clinical Observations, Body Weight and Mortality Data – Preliminary Screening Test
Concentration |
Animal Number |
Body Weight (g) |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Day 1 |
Day 6 |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
50 |
S-1 |
16.7 |
16.8 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0Fs |
0Fs |
0Fs |
0= No signs of systemic toxicity
Fs = Blue colored staining of the ears and fur
Local Skin Irritation – Preliminary Screening Test
Concentration |
Animal Number |
Local Skin Irritation |
|||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
||
50 |
S-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Measurement of Ear Thickness and Mean Ear Thickness Changes –Preliminary Screening Test
Concentration |
Animal Number |
Ear Thickness Measurement (mm) |
|||||
Day 1 |
Day 3 |
Day 6 |
|||||
pre‑dose |
post dose |
||||||
left |
right |
left |
right |
left |
right |
||
50 |
S-1 |
0.20 |
0.21 |
0.22 |
0.24 |
0.23 |
0.22 |
overall mean (mm) |
0.205 |
0.230 |
0.225 |
||||
overall mean ear thickness change (%) |
na |
12.195 |
9.756 |
na = Not applicable
Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration |
dpm |
dpm/Node [a] |
Stimulation Index [b] |
Result |
Vehicle |
8300.97 |
1037.62 |
na |
na |
10 |
9957.01 |
1244.63 |
1.20 |
Negative |
25 |
10209.09 |
1276.14 |
1.23 |
Negative |
50 |
10640.15 |
1330.02 |
1.28 |
Negative |
dpm = Disintegrations per minute
a = Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Individual Clinical Observations and Mortality Data
Concentration |
Animal Number |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
Vehicle |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
25 |
3-1 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
3-2 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
|
3-3 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
|
3-4 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
|
50 |
4-1 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
4-2 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
|
4-3 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
|
4-4 |
0 |
0Fs |
0 |
0Fs |
0 |
0Fs |
0 |
0 |
0 |
0 = No signs of systemic toxicity
Fs = Blue colored staining of the ears and fur
Individual Body Weights and Body Weight Change
Concentration |
Animal Number |
Body Weight (g) |
Body Weight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle |
1-1 |
20.3 |
20.7 |
0.4 |
1-2 |
16.6 |
17.4 |
0.8 |
|
1-3 |
19.8 |
21.1 |
1.3 |
|
1-4 |
20.0 |
20.4 |
0.4 |
|
10 |
2-1 |
19.5 |
22.0 |
2.5 |
2-2 |
20.8 |
20.2 |
-0.6 |
|
2-3 |
19.5 |
20.6 |
1.1 |
|
2-4 |
19.5 |
19.2 |
-0.3 |
|
25 |
3-1 |
18.7 |
20.0 |
1.3 |
3-2 |
16.8 |
16.5 |
-0.3 |
|
3-3 |
19.7 |
20.2 |
0.5 |
|
3-4 |
19.5 |
19.9 |
0.4 |
|
50 |
4-1 |
19.5 |
19.9 |
0.4 |
4-2 |
18.0 |
19.1 |
1.1 |
|
4-3 |
17.8 |
20.1 |
2.3 |
|
4-4 |
18.5 |
19.0 |
0.5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be a non-sensitizer under the conditions of the test.
- Executive summary:
FAT 20242/I was evaulated for skin sensitization potential according to OECD TG 429 following topical application to the dorsal surface of the mouse ear.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50 % w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test item as a suspension in dimethyl formamide at concentrations of 50 %, 25 % or 10 % w/w. A further group of four animals was treated with dimethyl formamide alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
At a concentration of 10 % in dimethyl formamide the stimulation index (SI) was 1.20 (negative).
At a concentration of 25 % in dimethyl formamide the stimulation index (SI) was 1.23 (negative).
At a concentration of 50 % in dimethyl formamide the stimulation index (SI) was 1.28 (negative).
The test item was considered to be a non-sensitizer under the conditions of the test. The test item does not meet the criteria for classification according to the Globally Harmonized Classification System.
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