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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 478-210-0 | CAS number: 69901-75-3
- 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:
- 2006-09-20 to 2007-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) and EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay) without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from "The Department of Health of the Government of the United Kingdom"
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material: VRT-126016
- Molecular weight: not applicable
- Smiles notation: not applicable
- InChl: not applicable
- Structural formula attached as image file: not applicable
- Substance type: no data
- Physical state: white powder
- Analytical purity: 99.8 % (area)
- Impurities: <0.5 % Z-D-cyclohexylglycine and <0.1 % chloride
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: 2006-02-02
- Lot/batch No.: batch 25719, lot 1-4107-6-02-02
- Expiration date of the lot/batch: 2008-02
- Stability under test conditions: no data
- Storage condition of test material: room temperature
- Other: received on 2006-09-15
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15.7-21.4 g
- Diet: A standard laboratory rodent diet (Special Diet Services RM1 (E) SQC) was provided ad libitum.
- Water: Drinking water was provided ad libitum.
- Acclimation period: 6 days
- Other: The mice were allocated without conscious bias to cages within the treatment groups.They were housed individually in polycarbonate cages with woodflake bedding. The mice were also given Nestlets for environmental enrichment.
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 21 +/- 2
- Humidity (%): 40-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES
- From: no data to no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: not applicable
- Vehicle:
- other: not applicable
- Concentration / amount:
- Not applicable
Challengeopen allclose all
- Route:
- other: not applicable
- Vehicle:
- other: not applicable
- Concentration / amount:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Challenge controls:
- Not applicable
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10, 25 and 50 % w/v
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS
- Compound solubility: Vehicle trials conducted with the test substance at 50 % w/v formed a thick paste in acetone:olive oil (4:1 v/v) which was too viscous for dose administration. At 50 % w/v in dimethylformamide, a clear solution was obtained which was satisfactory for dose administration. As dimethylformamide was the next preferred vehicle in the protocol, this was used for the study. The dosages were chosen based on the physical properties of the test substance (i.e. solubility, viscosity). The maximum practical concentration for pinna dosing was 50 % w/v in dimethylformamide. Based on this information, the dose levels of 10, 25 and 50 % w/v were used in the main study. Prior to dose administration, the Study Director authorized the choice of vehicle and dose levels in the raw data.
- Irritation: no data
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: incorporation of 3H-methyl Thymidine by B-scintillation counting of lymph node cell (LNC) suspensions
- Criteria used to consider a positive response: The test substance was regarded as a sensitizer if at least one concentration of the test substance resulted in a three-fold greater increase in 3HTdR incorporation compared to the control. Results were expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio).
TREATMENT PREPARATION AND ADMINISTRATION
The test substance formulations were prepared in the vehicle at the required concentrations freshly on each day of dosing. The absorption of the test substance was not determined. Chemical analysis of the homogeneity, stability and purity of the test substance was not undertaken as part of the study.
The mice were treated by daily application of 25 uL of the appropriate concentration of the test substance, to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was spread over the dorsal surface of each ear using the tip of an automatic micropipette. Another group of four mice received the vehicle alone in the same manner and further group received the positive control substance. Five days following the first topical application of the test substance (Day 6) all mice were injected via the tail vein with 250 uL of phosphate buffered saline containing 3H-methyl Thymidine (3HTdR: 80 uCi/mL) giving a nominal 20 uCi to each mouse. The injection into the tail vein was carried out using a plastic syringe and needle (26 guage) after the mouse had been heated in a warming changer.
All animals were observed daily for signs of ill health or toxicity. The ears were also examined for signs of irritation. The weight of each mouse was recorded on arrival (these data were not reported), Day 1 (first day of dosing) and prior to termination (Day 6).
Five hours following the administration of 3HTdR on Day 6, all mice were killed by carbon dioxide asphyxiation and the draining auricular lymph nodes excised and pooled for each experimental group. 1.0 mL of phosphate buffered saline was added to the pooled lymph nodes for each group. The animals were then discarded and no further investigations were carried out. The following procedures were carried out with the lymph nodes from these animals only.
1. Preparation of single cell suspensions: A single cell suspension of lymph node cells (LNC) was prepared by gentle mechanical disaggregation through a stainless steel gauze (200 mesh size). The pooled LNC were then washed by adding 10 mL phosphate buffered saline, pelleted at 190 x g for 10 minutes and resuspended. The cells were washed twice again and resuspended in 3 mL trichloroacetic acid (TCA: 5 %) following the final wash.
2. Determination of incorporated 3H-methyl Thymidine: after overnight incubation with 5 % TCA at 4 degrees C, the precipitate was recovered by centrifugation and resuspended in 1 mL 5 % TCA and transferred to 10 mL Ultima gold scintillation fluid on Day 7. 3HTdR incorporation was measured by B-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- -dpm=17870.40
-dpm/node (8)=2233.80
-positive control/control ratio=6.9
The positive control induced a positive result.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Test substance/control ratio- 10%= 1.8, 25 %=1.9 and 50%=2.9 As a SI of 3 or more was not recorded for any of the test substance groups, the test substance was considered not to have the potential to cause skin sensitization (delayed contact hypersensitivity).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM-10 %=4072.90, 25 %=4928.60 and 50 %=7573.90 DPM/node- 10 %=581.84, 25 %=616.08 and 50 %=946.74
Any other information on results incl. tables
Results:
There were no deaths and no signs of ill health or toxicity observed during the study. Wet fur, cranial area, was noted for all vehicle control, positive control and test animals post dose from Day 1. This sign had resolved by Day 2 in the positive control group and by Day 4 in the vehicle and low and mid dose groups and by Day 5 in the high dose group. Greasy fur, cranial region, was seen in all animals in the positive control group post dose from Day 1 resolving by Day 5. In addition white dose residue was seen on the ears and the fur around the ears, in all animals in the high dose group post dose from Day 1 and Day 3 only for 2 females from the mid dose group. This sign had resolved by Day 4 in the two animals from the mid dose group and was still present on Day 6 at study termination in all animals from the high dose group. One female in the vehicle control group lost weight at study termination. All remaining animals had satisfactory weight gains during the study.
Applicant's summary and conclusion
- Conclusions:
- This study was performed to assess the skin sensitization potential of the test substance using the murine local lymph node assay. Based on the results, the test substance was not regarded as a potential skin sensitizer.
- Executive summary:
Not applicable
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.