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EC number: 471-920-1 | 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:
- 2006-03-29 to 2006-08-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- - Substance type: amber liquid
- Analytical purity: Stable in accordance with MSDS
- Storage condition of test material: room temperature and humidity
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: The Jackson Laboratory, Bar Harbor, Maine, USA
- Age at study initiation: 10 weeks
- Weight at study initiation: 16 to 22 g
- Housing: 1 per cage, suspended wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 2006-03-29 To: 2006-04-07
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1%, 2.5%, 5%, 10%, or 25% v/v in vehicle
- No. of animals per dose:
- 5 per dose.
- Details on study design:
- ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay in the Mouse. The assay has undergone extensive inter-laboratory validation and has been shown to reliably detect test materials that are moderate to strong sensitisers.
- Criteria used to consider a positive response: For each animal, the LNC suspension was analyzed for BrdU incorporation and total number of LNC by flow
cytometry. The amount of proliferating (#BrdU+) LNC was determined as a measure of the proliferative response of the local lymph node. The stimulation index (SI) was calculated by dividing the proliferative response (BrdU incorporation) of each test article group by the proliferative response of the vehicle
control group. Test articles that yielded a SI ≥ 3 were characterized as sensitizing substances.
TREATMENT PREPARATION AND ADMINISTRATION: Groups of 5 mice were treated with increasing concentrations of 1%, 2.5%, 5%, 10% and 25% v/v in acetone/olive oil 4:1. 25 µL of test material to dorsal surface of each ear for three consecutive days. Admisistered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. Further groups of five mice received either the vehicle alone or the positive control (25% HCA in the vehicle) in the same manner. All animals were observed once daily throughout the study and any siigns of toxicity or ill health recorded. Bodyweights were recorded on Day 1 (prior to dosing) and on Day 6. Ear measurements were taken from all animals and recorded on Days 1, 3 and 6.
Five days following the initial dose, and five hours prior to sacrifice, the mice were given an intraperitoneal injection of the thymidine analog 5-bromo-2’-deoxy-uridine (BrdU), and at sacrifice the auricular lymph nodes were isolated and single-cell suspensions of lymph node cells (LNC) were generated.
The concentration at which SI = 3 (EC3) was calculated for each test article. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Eliminating outliers: One value, from the 5% OS 21 5085 group, was identified as an outlier by the statistical Q-test’ for rejection of data points from a sample group. This animal exhibited an uncharacteristic (out of historical range) lymph node cell number and %BrdU+ counts. This may be due to a pre-existing viral or bacterial infection, or other physiological or immune system aberration. Inclusion or rejection of the outlier value did not alter the conclusion or the prediction of sensitizing potential.
Results and discussion
- Positive control results:
- 25% HCA: SI = 12.0 (S.D. = ±3.7)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 8.5
- Variability:
- 3.6
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 3.3
- Variability:
- 1.8
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1
- Variability:
- 0.4
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Variability:
- 1.6
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Variability:
- 0.5
- Test group / Remarks:
- 1%
Any other information on results incl. tables
The EC3 value for test article could be determined because all test article concentrations below 5% had a SI ‘3, and all test article concentrations above 10% had SI values 23. The dose response was calculated to cross the threshold (SI=3) at 9.4%
Table 1: Stimulation Index
Treatment |
SI |
S.D |
Acetone/olive oil 4:1 |
1.0 |
(± 0.4) |
25% HCA (+ve control) |
12.0a |
(± 3.7) |
1% |
1.3a |
(± 0.5) |
2.5% |
2.3 |
(± 1.6) |
5% |
1.0 |
(±0.4) |
10% |
3.3a |
(± 1.8) |
25% |
8.5a |
(± 3.6) |
a: A SI≥3 indicates a sensitising response. The SI was calculated by dividing the mean number of proliferating lymph node cells (#BrdU+) from each treatment group by the mean number of proliferating cells from the vehicle group.
All animals survived the in-life phase of the study and appeared normal.
Body weight changes were normal. Ear swelling measurements and individual animal observations indicated that dermal irritation occurred at the 25% treatment.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Topical application of the test article resulted in dermal (ear) irritation at the highest dose tested, 25%. In addition, at concentrations between 10% and 25% of the test article, Stimulation Index values were greater than 3 (SI > 3.0), and therefore this test article is a dermal sensitizer in the Local Lymph Node Assay. The EC3 value for the test article was calculated to be 9.4%.
- Executive summary:
Test Guidance
OECD 429 and US EPA OPPTS 870.2600
Method and materials
For the definitive study, ten separate groups of five healthy female CBNJ mice were treated with increasing concentrations of the test article by topical application to the dorsum of each ear, once daily for three consecutive days. A vehicle control group of five mice was treated with Acetone/Olive Oil (4:l) (AOO) and another group of five mice were treated with the positive control, 25%
HCA (in AOO), in the exact same manner.
Five days following the initial dose, and five hours prior to sacrifice, the mice were given an intraperitoneal injection of the thymidine analog 5-bromo-2’-deoxy-uridine (BrdU), and at sacrifice the auricular lymph nodes were isolated and single-cell suspensions of lymph node cells (LNC) were generated. For each animal, the LNC suspension was analyzed for BrdU incorporation and total number of LNC by flow cytometry. The amount of proliferating (#BrdU+) LNC was determined as a measure of the proliferative
response of the local lymph node. The stimulation index (SI) was calculated by dividing the proliferative response (BrdU incorporation) of each test artrcle group by the proliferative response of the vehicle control group. Test articles that yielded a SI 2 3 were characterized as sensitizing substances.
The concentration at which SI = 3 (EC3) was calculated for each test article.
Results
All animals survived the in-life phase of the study and appeared normal. There were no difficulties in administration of the test article or with its adherence to the dosed ears. For all animals, body weight changes were normal. Ear swelling measurements
and individual animal observations indicated that the 25% treatment for the test article resulted in dermal irritation.
The SI of the positive control, 25% HCA, was 12.0, consistent with historical data.
The SI values for the test article at 1%, 2.5,% , 5%, 10% and 25% were 1.3, 2.3, 1.0, 3.3 and 8.5, respectively.
Conclusions
Topical application of the test article resulted in dermal (ear) irritation at the highest dose tested, 25%. In addition, at concentrations between 10% and 25% of the test article, Stimulation Index values were greater than 3 (SI > 3.0), and therefore this test article is a dermal sensitizer in the Local Lymph Node Assay. The EC3 value for thes test article was calculated to be 9.4%.
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