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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 481-870-2 | 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:
- Between 09 may 2007 and 15 May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- No
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaBkl)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: B & K Universal Ltd, hull, UK
- Age at study initiation: 8 to 12 weeks old.
- Weight at study initiation: 15 to 23 g.
- Housing: Individually housed in suspended solid-floor plypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to food (Certified Rat and Mouse Diet)
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approx 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06.00 to 18.00) and 12 hours darkness
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Groups of four mice were treated with the test material at concentrations of 5%, 10% or 25% w/w in dimethyl formamide.
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
Information available suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration.
- Compound solubility: For the purpose of the study, the test material was freshly prepared in dimethyl formamide. This vehicle was chosen as it produced the highest concentration that was suitable for dosing. 25%: 1g of 50% dilution made up to 2g
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- 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 (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
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:
Preparation:
For the purpose of the study, the test material was freshly prepared in dimethyl formamide. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.
Administration:
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 for three consecutive days (Days 1, 2, 3). 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.
A further group of four mice received the vehicle alone in the same manner. - Positive control substance(s):
- other: alpha-Hexylcinnamaldehyde, Tech, 85%
- Statistics:
- None provided.
Results and discussion
- Positive control results:
- Three groups, each of five animals, were treated with 50 µl (25 µl per ear) of alpha- Hexylcinnamaldehyde, Tech, 85% as a solution in dimethyl formamide at concentrations of 5%, 10% and 25% v/v. A further control group of five animals was treated with dimethyl formamide alone.
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 (% v/v) in dimethyl formamide: 5
Stimulation Index: 2.81
Result: Negative
Concentration (% v/v) in dimethyl formamide: 10
Stimulation Index: 4.20
Result: Positive
Concentration (% v/v) in dimethyl formamide: 25
Stimulation Index: 13.15
Result: Positive
alpha-Hexylcinnamaldehyde, Tech, 85% was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Concentration (% w/w) in dimethyl formamide Vehicle: na 5: S.I of 1.86 10: S.I of 1.68 25: S.I of 1.69
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Concentration (% w/w) in dimethyl formamide Vehicle: 3962.96 dpm 5: 7376.88 dpm 10: 6653.06 dpm 25: 6695.16
Any other information on results incl. tables
The radioactive disintegrations per minute per lymph node and the stimulation index are given in Table 1.
A stimulation index of less than 3 was recorded for the three concentrations of the test material (5%, 10% and 25% w/w in dimethyl formamide).
Table1 Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration (% w/w) in |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
3962.96 |
496.37 |
na |
na |
5 |
7376.88 |
922.11 |
1.86 |
Negative |
10 |
6653.06 |
831.63 |
1.68 |
Negative |
25 |
6695.16 |
836.90 |
1.69 |
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
Clinical Observations and Mortality Data
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Purple/pink-coloured staining to the ears and fur was noted in all test animals post-dose on Day 1 and for the remainder of the test.
Bodyweight
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.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A stimulation index of less than 3 was recorded for the three concentrations of the test material (5%, 10% and 25% w/w in dimethyl formamide).
The test material was considered to be a non‑sensitiser under the conditions of the test. - Executive summary:
A 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)
§ Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC
Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl formamide at concentrations of 5%, 10% or 25% w/w. A further group of four animals was treated with dimethyl formamide alone.
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 dimethyl formamide
Stimulation Index
Result
5
1.86
Negative
10
1.68
Negative
25
1.69
Negative
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.