Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 943-665-0 | 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:
- The study was conducted between 20 May 2016 and 02 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- EC 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Batch/Lot No. 5399661C10
- Expiration date of the lot/batch: 19 January 2020
- Purity test date: 19 January 2016
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS:
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc, The Netherlands
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: 8 - 12 wks
- Weight at study initiation: 15 - 23 g
- Housing: Suspended solid floor polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
- Indication of any skin lesions: None
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ”C
- Humidity (%): 30 - 70%
- Air changes (per hr): >15/h
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 20 May 2016 To: 01 June 2016
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- Preliminary screening = 10% w/w in vehicle
Main Test = 10%, 5% or 2.5% w/w in vehicle - No. of animals per dose:
- Preliminary screening = one mouse at 10% w/w
Main Test = 5/dose level - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: 10% w/w = maximum attainable concentration in vehicle
- Irritation:
- Systemic toxicity:
- Ear thickness measurements: mean thickness >25% indicated excessive irritation
- Erythema scores:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer".
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of five mice were treated with the test item at concentrations of 10%, 5% or 2.5% w/w in propylene glycol. 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 five mice received the vehicle alone in the same manner.
The positive control animals were similarly treated to the test animals except that 25 μL of the positive control item, Phenylacetaldehyde (>90%), at a concentration of 5% v/v in propylene glycol was applied to the dorsal surface of each ear. - Positive control substance(s):
- other: Phenylacetaldehyde
- Statistics:
- Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships. Data was first assessed for suitability by analysis of normality and homogeneity of variance. If the assumptions that the data are both normally distributed and has homogeneity of variances, then parametric one way analysis of variance (ANOVA) and Dunnett’s multiple comparison procedure were used to determine statistical significance. If the assumptions were not met, non-parametric Kruskal-Wallis Rank Sum and Mann-Whitney U test procedures were used.
Results and discussion
- Positive control results:
- Positive control dosed at 5% w/w in propylene glycol gave a positive response with a Stimulation Index of 9.67
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- 2.5% w/w in propylene glycol
- Value:
- 1.22
- Test group / Remarks:
- negative
- Key result
- Parameter:
- SI
- Remarks:
- 5% w/w in propylene glycol
- Value:
- 0.99
- Test group / Remarks:
- negative
- Key result
- Parameter:
- SI
- Remarks:
- 10% w/w in propylene glycol
- Value:
- 1.07
- Test group / Remarks:
- negative
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA See Table 1
DETAILS ON STIMULATION INDEX CALCULATION SI expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group.
EC3 CALCULATION
CLINICAL OBSERVATIONS: There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS 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.
Any other information on results incl. tables
Table 1: Estimation of the Proliferative Response of Lymph Node Cells (Cellular Proliferation Data)
Treatment Group | Concentration in Vehicle | Stimulation Index | Result |
Test Item | 2.5% w/w | 1.22 | Negative |
Test Item | 5.0% w/w | 0.99 | Negative |
Test Item | 10% w/w | 1.07 | Negative |
Positive control | 5% w/w | 9.67 | Positive |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Non-sensitizer
- Conclusions:
- The test item was considered to be a non-sensitizer under the conditions of the test.
The positive control Phenylacetaldehyde (>90%) gave a Stimulation Index of greater than 3 (9.67) when tested at a concentration of 25% - Executive summary:
A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a maximum attainable concentration of 10% 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 five animals, were treated with 50 μL (25 μL per ear) of the test item as a suspension in propylene glycol at concentrations of 10%, 5% or 2.5% w/w. A further group of five animals was treated with propylene glycol alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitizer, Phenylacetaldehyde (>90%), at a concentration of 5% v/v in propylene glycol.
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 in Table 1 above.
Conclusion
The test item was considered to be a non-sensitizer under the conditions of the test.
The positive control Phenylacetaldehyde (>90%) gave a Stimulation Index of greater than 3 (9.67) when tested at a concentration of 25% v/v in propylene glycol, thus, demonstrating the sensitivity and reliability of the test system.
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.
Hoewel ECHA veel materiaa in uw taal online heeft, is een deel van deze pagina in het Engels. Meer informatie van ECHA over meertaligheid.
Welkom op de ECHA-website. In Internet Explorer 7 (en vroegere versies) wordt deze site niet volledig ondersteund. U schakelt het best op een recentere versie van Internet Explorer over.
Deze website maakt gebruik van cookies om het surfen zo aangenaam mogelijk te maken.
Lees meer over hoe wij cookies gebruiken.