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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 to 30 June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant with OECD 429 and GLP guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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
- Details on test material:
- Name: Golden Yellow Continuous
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species and strain: CBA/J@Rj mice
- Source: ELEVAGE JANVIER, Route des Chènes Secs B.P. 4105, 53940 LE GENEST-ST-ISLE, France
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 21.3–22.8 grams
- Housing: single
- Diet: ssniff SM R/M-Z+H ad libitum
- Water: tap water ad libitum
- Acclimation period: 27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24 to 30 June 2009
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 2.5%, 5%, 10%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: max 10% in DMSO
- Irritation: no
- Lymph node proliferation response: NA
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node proliferation assay with incorporated tritiated thymidine
- Criteria used to consider a positive response:
-- exposure to at least one concentration resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
AND
-- data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Each mouse was topically dosed with 25 µl of the appropriate formulation (1%, 2.5%, 5%) of the test item using a pipette, on the dorsal surface of each ear. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- DPM: 8422.5
DPN: 1052.8
SI: 6.6
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 2.5%: 2.6 5. 0%: 1.7 10%: 1.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 2.5%: 3232.5 5. 0%: 2190.5 10%: 2057.5
Any other information on results incl. tables
Test Group Name |
Measured DPM/group |
DPM |
No. of LNN |
DPN |
Stimulation Index Values |
Background 5 (w/v) % TCA |
35.5 |
- |
- |
- |
- |
Negative control DMSO |
1303.0 |
1267.5 |
8 |
158.4 |
1.0 |
Golden Yellow Continuous |
2093.0 |
2057.5 |
8 |
257.2 |
1.6 |
Golden Yellow Continuous |
2226.0 |
2190.5 |
8 |
273.8 |
1.7 |
Golden Yellow Continuous |
3268.0 |
3232.5 |
8 |
404.1 |
2.6 |
Positive control |
8458.0 |
8422.5 |
8 |
1052.8 |
6.6 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under the conditions of the present assay, Golden Yellow Continuous, tested in a suitable vehicle, proved to have no sensitizing potential (non-sensitizer) in the Local Lymph Node Assay.
- Executive summary:
The aim of this study was to determine the skin sensitisation potential of Golden Yellow Continuous following dermal exposure.
Based on results of the Preliminary Compatibility Test and on recommendations of the OECD Test Guideline 429, the test item was dissolved in Dimethyl-sulphoxide (DMSO). The maximum attainable concentration based on solubility of the test item in DMSO was 10%.
A Preliminary Irritation/Toxicity Test was performed with the test item at concentrations of 10% and 5% in the selected vehicle. According to this test, the applicability and biocompatibility of the test item to the animals’ ears (2 female CBA/J@Rj mice/dose) at the maximum concentration of 10% was acceptable.
In the main assay twenty female CBA/J@Rj mice were allocated to five groups of four animals each:
- three groups received the appropriate formulation of Golden Yellow Continuous at concentrations of 10%, 5% and 2.5%,
- the negative control group received the vehicle (DMSO),
- the positive control group received 25% alpha-Hexylcinnamaldehyde (HCA) in DMSO.
The test item solutions were applied to the dorsal surface of both ears of the mice (25 µL/ear) for three consecutive days (Days 1, 2, and 3). There was no treatment on Days 4, 5, and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).
No mortality or systemic clinical signs were observed during the study. No treatment related effects were observed on animal body weights in any of the treated groups. No cutaneous reactions were observed at the site of the treatment in any of the treated groups.
No significant lymphoproliferative response (SI ³ 3) of Golden Yellow Continuous was observed at the concentrations applied compared to the negative control. The stimulation index values of the test item were 1.6, 1.7, and 2.6 at treatment concentrations of 10%, 5%, and 2.5%, respectively. No conventional dose-response to treatment was observed.
A significant lymphoproliferative response (stimulation index value of 6.6) was noted for the positive control chemical HCA. This result confirmed the validity of the assay.
In conclusion, under the conditions of the present assay Golden Yellow Continuous, tested in a suitable vehicle, proved to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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