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EC number: 220-701-7 | CAS number: 2871-01-4
- 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:
- From 3 July 2001 to 7 November 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No pre screen test was perform in order to determine the test dose. Control and Test groups were composed by 3 animals. The current OECD Guideline required a minimum of 4 animals per dose group.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Experimental groups of 3 animals were used instead of 4 required by OECD method
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-(4-amino-2-nitroanilino)ethanol
- EC Number:
- 220-701-7
- EC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Cas Number:
- 2871-01-4
- Molecular formula:
- C8H11N3O3
- IUPAC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Test material form:
- solid: particulate/powder
- Remarks:
- Green/Brown crystalline powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Supplied by Unilever, Lot L-28231
- Expiration date of the lot/batch: not specifed
- Purity test date: 18 December 2002
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original containers at room temperature (17-20°C) in the dark
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: samples were stable during 9 month under ambient conditions
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item and vehicle (acetone:olive oil, 4:1 (v/v)) were placed into a glass beaker on a tared Mettler balance and weight/volume dilutions were prepared. Homogeneity of the test item in vehicle was maintained during treatment using a magnetic stirrer. The preparations were made immediately prior to dosing.
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 (Netherlands)
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: not specified
- Age at study initiation: 7-12 weeks
- Weight at study initiation: 12.6-25.4g
- Housing:In groups of three in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433 ad libitum
- Water (e.g. ad libitum):Community tap water from Itingen available ad libitum
- Acclimation period: 6 days of acclimation
- Indication of any skin lesions: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70% relative humidity
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light / 12 hour dark cycle with at least 8 hours music during the light period
- IN-LIFE DATES: From: 10 July 2010 To: 25 July 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 0.10, 0.25, 0.50, 1.00, 2.50% (w/v)
- No. of animals per dose:
- 3 animals were used per dose
- Details on study design:
- PRE-SCREEN TESTS:
No screen test were performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Animals were assignated randomly by computer algorithm
- Criteria used to consider a positive response:
A test item is regarded as sensitizer in a LLNA if the following criterias are fulfilled
-That exposure to at least one concentration of the test item resulted in an incorporation of radiolabelled thymidine at least 3 fold or greater than that recorded in control miice, as indicated by the stimulation index
-That the data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression
TREATMENT PREPARATION AND ADMINISTRATION: The preparations of the test item were made immediately prior each dosing. Mice were treated by (epidermal) topical application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of in acetone:olive oil 4:1. The application volume, 25µL, was spread over the entire dorsal surface of each ear lobe once daily for three consecutive days. A further group of mice were treated with an equivalent volume of the relevant vehicle alone (control animal). A hair dryer was used to dry the ear's surface as quickly as possible to avoid loss of test item applied.
Five days after topical application, the mice were administered with 250µL of radiolabelled thymidine (specific activity 2Ci/mmol ; concentration 1 mCi/mL) by intravenous injection via a tail vein. Five hours later, mice were euthanized.The draining lymph node were excised and pooled for each experimental group. They were washed and resuspended with trichloroacetic acid (at 5%) and incubated overnight at 4°C. The precipitates were resuspended in trichloroacetic acid (at 5%) and transferred to glass scintilation vials in order to count the incorportation of radiolabelled thymidine by Beta-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- Stimulation indices of 2.4, 3.7 and 7.0 were determined at a concentration of 5, 10 and 25% of positive control in acetone:olive oil 4:1 (v/v). It induced sensitising effects when tested at concentrations of 10% and 25%.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- 0.10%
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 0.25%
- Key result
- Parameter:
- SI
- Value:
- 1.9
- Test group / Remarks:
- 0.50%
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 1.00%
- Key result
- Parameter:
- SI
- Value:
- 3.3
- Test group / Remarks:
- 2.50%
- Key result
- Parameter:
- other: dpm per lymph node
- Value:
- 467
- Test group / Remarks:
- Vehicle control group
- Cellular proliferation data / Observations:
- No evidence of stimulating allergic contact sensitisation when HC Red n° 3 was tested at 0.1%, 0.25%, 0.5% and 1.0% (w/v) as the mean stimulation index did not exceed a value of 3, but HC Red n° 3 showed a positive lymphocyte proliferative increase when tested at 2.5% (w/v).
Any other information on results incl. tables
Table 1 :Summary of the results
Concentration % (w/v) |
Mean Stimulation Index (SI) |
|
HC Red n° 3 |
Alpha Hexylcinnamaldehyde |
|
0.1 |
0.5 |
- |
0.25 |
1.2 |
- |
0.5 |
1.9 |
- |
1.0 |
1.8 |
- |
2.5 |
3.3 |
- |
5.0 |
- |
2.4 |
10.0 |
- |
3.7 |
20.0 |
- |
7.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the experimental condition of the study, the HC Red No. 3 at the concentration of 2.5% induced contact allergenic effect when administered to the dorsum of ear lobes in mice. HC Red n° 3 was sensitising when tested at 2.5%. Hence the test item was classified as sensitizer Category 1A strong sensitiser according to the CLP criterias. However, this study had some deviations as the insufficient number of animals per group (3 were used instead of 4 required in the OECD guideline) but the results were still relevant.
- Executive summary:
The purpose of this GLP compliant study was to identify the contact allergenic potential of the test item HC Red No. 3 when applied to the dorsum of both ear lobes of mice in a LLNA test performed according to OECD 429 method.
Concentrations of 0, 0.1, 0.25, 0.5, 1.0 and 2.5% HC Red 3 (w/v) in acetone:olive oil, 4:1 (v/v) applied topically to the dorsum of each ear lobe of CBA/CaOlaHsd mice (left and right) (25 µl per ear) once daily on 3 consecutive days.
On day 5, mice were injected intravenously with 250 µl of 3H-methyl thymidine (21.44 µCi). Five hours later (six hours with positive control), mice were euthanized and the draining auricular lymph nodes removed. Lymph nodes from each animal within a dose group were pooled and a cell suspension prepared. After three phosphate buffered saline washes, cells were precipitated in 3 ml of 5% trichloroacetic acid (TCA) at 4°C overnight. Samples were resuspended in 1 ml of 5% TCA and transferred to scintillation vials containing 10 ml of scintillation fluid and analysed.
No evidence of stimulating allergic contact sensitisation when HC Red n° 3 was tested at 0.1%, 0.25%, 0.5% and 1.0% (w/v) as the mean stimulation index did not exceed a value of 3, but HC Red n° 3 showed a positive lymphocyte proliferative increase when tested at 2.5% (w/v).
Under the experimental condition of the study, the HC Red No. 3 at the concentration of 2.5% induced contact allergenic effect when administered to the dorsum of ear lobes in mice. HC Red n° 3 was sensitising when tested at 2.5%. Hence the test item was classified as sensitizer Category 1A strong sensitizer according to CLP criterias. However, this study had some deviations as the insufficient number of animals per group (3 were used instead of 4 required in the OECD guideline) but the results were still relevant.
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