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EC number: 486-070-7 | 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:
- from 14 September 2007 to 01 November 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- yes
- Remarks:
- The relative humidity in the animal room was between approximately 30 - 85 % (instead of a maximum of 70%). This deviation had no detrimental impact on the outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst, The Netherlands
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 19.4 to 23.4 g
- Housing: Individually in Makrolon type-1 cages with wire mesh top (EHRET GmbH, D-79302 Emmendingen) and with granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
- Diet: pelleted standard diet (Harlan Winlkelmann Gmbh, D-33178 Borchen), ad libitum
- Water: tap water (Gemeindewerke, D64380 Rossdorf), ad libitum
- Acclimation period: at least 5 days prior to the start of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-85%
- Air changes (per hr): information not available
- Photoperiod (hrs dark / hrs light):6/6
IN-LIFE DATES: From 18 September 2007 to 02 October 2007
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, 25, 50 and 100% (w/v) in acetone:olive oil (4+1)
- No. of animals per dose:
- 4 per dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility and irritation:
A pre-test was performed on 2 mice to determine the highest non-irritant test concentration, or the highest technically applicable concentration. The data showed that the highest test item concentration, which could be technically used was 100%. At concentrations of 10, 25, 50 and 100%, the notified substance did not show any signs of irritation. Therefore, in the main assay, concentrations applied were 5, 10, 25, 50 and 100%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
Exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index and data are compatible with a conventional dose response (allowing for either local toxicity or immunological suppression).
TREATMENT PREPARATION AND ADMINISTRATION:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 5, 10, 25, 50, and 100% (w/v) in acetone:olive oil (4+1). The application volume, 25 µl, was spread over the entire dorsal surface of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
Five days after the first topical application, all mice were administered with 250 µl of 78.2 µCi/ml 3H-methyl thymidine (corresponds to 19.6 µCi 3HTdR per mouse) by intravenous injection via a tail vein.
Prior to the first application of the test item and prior to treatment with 3HTdR.the ear thickness was determined using a micrometer .
Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Pentobarbital-Natrium. The draining lymph nodes were rapidly excised and pooled per group (8 nodes/group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze. After washing two times with phosphate buffered saline, the lymph node cells were resuspended in 5 % trichloroacetic acid and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid and transferred to plastic scintillation vials with 10 ml of ‘Ultima Gold’ scintillation liquid and thoroughly mixed. The level of 3HTdR incorporation was then measured on a beta-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. The beta-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
An aliquot of 50 µL of the cell suspension was diluted with an equal amount of trypan bule solution and the number of viable cells was determined using a Neubauer chamber. Results were expressed as cells per lymph node.
After the lymph nodes have been excised, both ears of mice were punched at the apical area using a biopsy punch. For each animal both punches were immediately weighed per animal using an analytical balance.
The proliferative response of lymph node cells is expressed as DPM/node and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (stimulation index). Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test and control raw data. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
For the ear weights the ANOVA (Dunnett-test) was conducted to assess whether the difference is statistically significant between test item groups and negative control (vehicle) group. Statistical significance was at the five per cent level (p < 0.05). However, both biological and statistical significance were considered together.
Results and discussion
- Positive control results:
- Experiment performed in May 2007 usin gCBA/CaOlaHsd mice gave the following results for alpha-Hexylcinnamaldehyde in acetone:olive oil (4+1):
2.43 at 5%
4.07 at 10%
4.88 at 25%
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.12
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 0.98
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 0.76
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 0.61
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 0.55
- Test group / Remarks:
- 100%
Any other information on results incl. tables
When cell counts were analysed for the same lymph node preparations, Stimulation indices (S.I.) of 1.08, 0.94, 1.14, 0.99 and 0.94 were determined at concentrations of 5, 10, 25, 50 and 100%, respectively.
The EC3 (concentration of the test
material required to produce a 3-fold increase in draining lymph node
cell proliferative activity) value could not be calculated since none of
the tested concentrations induced a S.I. greater than 3.
Other observations:
The animals did not show any clinical signs during the
course of the study and no case of mortality were observed. There were
no signs of local irritation following application for 3 consecutive
days.
No relevant increase in ear thickness and no statistically
significant increase in ear weights were determined.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study the stimulation indices (S.I.) of 1.12, 0.98, 0.76, 0.61 and 0.55 were determined with the test item at concentrations of 5, 10, 25, 50 and 100% in acetone:olive oil (4+1). The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.The test material Dimethyl 2-methylglutarate was found not to be a skin sensitiser under the described conditions.
Dimethy 2-methylglutarate is not classified as a skin sensitiser according to the criteria of Annex VI Directive 67/548/EEC and EU GHS - Executive summary:
In the study the test material Dimethyl 2-methylglutarate dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed in CBA/CaOlaHsd mice using test material concentrations of 5, 10, 25, 50, and 100%.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. No relevant increase in ear thickness and no statistically significant increase in ear weights were determined.
In this study Stimulation Indices (S.I.) of 1.12, 0.98, 0.76, 0.61, and 0.55 were determined for incorporation of 3H-thymidine with the test material at concentrations of 5, 10, 25, 50, and 100% in acetone:olive oil (4+1), respectively. When cell counts were analysed for the
same lymph node preparations Stimulation Indices (S.I.) of 1.08, 0.94, 1.14, 0.99, and 0.94 were determined.
Dimethyl 2-methylglutarate is not considered as a skin sensitiser according to the criteria of Annexe VI Directive 67/548/EEC and EU GHS.
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.
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