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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:
- 10/12/2008 to 16/12/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised 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:
- No further information required.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: Eight to twelve weeks old
- Weight at study initiation: 15 to 23 g
- Housing: The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains tap water was allowed throughout the study.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
Study design: in vivo (non-LLNA)
- Challenge controls:
- n/a
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrobenzenesulfonic acid, sodium salt
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% pluronic L92 in distilled water.
- Concentration:
- 1% pluronic L92 in distilled water.
- No. of animals per dose:
- 4 mice
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: For the purpose of the study, the test material was freshly prepared as a solution in 1% pluronic L92 in distilled water. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.
- Irritation: Information available suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration.
- Lymph node proliferation response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node and as the ratio of ^3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002) and Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/731EC.
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node and as the ratio of ^3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes. The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in ^3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in ^3HTdR incorporation will be classified as a "non-sensitiser".
TREATMENT PREPARATION AND ADMINISTRATION:
MAIN STUDY
- No. of exposures: 3
- Test groups: Groups of four mice were treated with the test material at concentrations of 25%, 10% or 5% w/w in 1% pluronic L92 in distilled water.
- Control group: A further group of four mice received the vehicle alone in the same manner.
- Site: The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
- Frequency of applications: The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear.
- Duration: three consecutive days (Days 1, 2, 3).
- Concentrations: 25%, 10% or 5% w/w in 1% pluronic L92 in distilled water. - Positive control substance(s):
- other: 2,4-Dinitrobenzenesulfonic acid, sodium salt
- Statistics:
- n/a
Results and discussion
- Positive control 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 are as follows:
Concentration (% w/w) in 1% pluronic L92 in distilled water Stimulation Index Result
1 0.96 Negative
5 4.29 Positive
10 13.15 Positive
Therefore, 2,4-Dinitrobenzenesulfonic acid, sodium salt was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: A stimulation index of less than 3 was recorded for the three concentrations of the test material (25%, 10% and 5% w/w in 1% pluronic L92 in distilled water).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration (%w/w) in 1% pluronic L92 in distilled water dpm dpm/Node(a) Stimulation Index(b) Result Vehicle 5383.57 672.95 na na 5 5151.07 643.88 0.96 Negative 10 2869.31 358.66 0.53 Negative 25 5486.88 685.86 1.02 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
Any other information on results incl. tables
A stimulation index of less than 3 was recorded for the three concentrations of the test material (25%, 10% and 5% w/w in 1% pluronic L92 in distilled water).
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Blue coloured staining of the ears and fur was noted, post dose on Days 1 to 3, in animals treated with the test material at concentrations of 25% or 10% w/w in 1% pluronic L92 in distilled water.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
In a local lymph node assay in the mouse study (Harlan project number: 0959/0230) the test material was considered to be a non-sensitiser under the conditions of the test.
The study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:
- OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002).
- Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/731EC.
A stimulation index of less than 3 was recorded for the three concentrations of the test material (25%, 10% and 5% w/w in 1% pluronic L92 in distilled water).
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Blue coloured staining of the ears and fur was noted, post dose on Days 1 to 3, in animals treated with the test material at concentrations of 25% or 10% w/w in 1% pluronic L92 in distilled water.
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
The test material was considered to be a non-sensitiser under the conditions of the test.
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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