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EC number: 202-485-6 | CAS number: 96-17-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (no individual caging, test substance concentrations were not in consecutive order)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- : no individual caging, test substance concentrations were not in consecutive order
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-methylbutyraldehyde
- EC Number:
- 202-485-6
- EC Name:
- 2-methylbutyraldehyde
- Cas Number:
- 96-17-3
- Molecular formula:
- C5H10O
- IUPAC Name:
- 2-methylbutanal
- Details on test material:
- - Name of test material (as cited in study report): 2-methyl butyraldehyde
- Physical state: clear colorless liquid
- Analytical purity: 98.2 ± 0.06 %
- Impurities (identity and concentrations): 0.049 wt% water, 0.3%, 0.9% and 0.3% not identified substances A, B, and C
- Purity test date: no data
- Lot/batch No.: TK2632B-16OCT2007
- Stability under test conditions: stable, recertification date January 31, 2010
- Storage condition of test material: no data
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, Indianapolis, IN, USA
- Age at study initiation: approx. 10 - 11 weeks
- Weight at study initiation:
- Housing: up to 6 per cage in filter tubs containing corncob bedding
- Diet (e.g. ad libitum): LabDiet Certified Rodent Diet #5002 (PMI Nutrition International, St. Louis, MO, USA) in pelleted form, ad libitum
- Water (e.g. ad libitum): municipal drinking water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 40 - 70
- Air changes (per hr): 12 - 15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 25, and 100 % test substance in vehicle
- No. of animals per dose:
- 6
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: soluble in vehicle
- Application: one female mouse was used per concentration (1%, 5%, 25%, 50%, 75%, and 100% of test substance). Animals received one application of test solution on three consecutive days spread on the dorsal surface of each ear (25µL/ear) in a manner to prevent material loss
- Irritation: pure (100%) test substance caused slight erythema at day 3 which resolved by day 6
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a response positive: a stimulation index (SI) of ≥ 3 (i.e., 3-fold greater proliferation than control animals) is considered positive for dermal sensitization potential of the test substance
TREATMENT PREPARATION AND ADMINISTRATION
- Test solutions:Test solutions were prepared daily just prior to dosing. Concentrations were not verified analytically.
- Administration: test material (25 µL/ear) was administered once daily for three consecutive days on the dorsal surface of both ears using an adjustable pipette as for the range finding test.
OBSERVATIONS
- Visual control of ears, evaluation of erythema: prior to application and on day 2, 3 and 6
- Weighing: on day 1 and 6
TREATMENT WITH 3H-THYMIDINE AND PREPARATION OF LYMPH NODE CELL SUSPENSION
- 3H-Thymidine treatment: on day 6 five hours prior to sacrifice, all mice received a 250 µL intravenous injection via the lateral tail vein containing 20 µCi of 3H-thymidine (specific activity 2Ci/mmol) diluted in phosphate buffered saline (PBS).
- Isolation of lymph nodes: both of the auricular lymph nodes per mouse were excised. Single cell suspensions in PBS were prepared by gentle mechanical disaggregation using a tissue homogenizer. Cells were washed twice and suspended in trichloroacetic acid for approx. 18 h. The resulting precipitate was separated by centrifugation and the radioactivity in each precipitate was measured using ß-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Means and standard deviation (SD) were generated for body weight data (absolute and gain) and the LLNA response (dpm & SI values).
Body weight and dpm data were analyzed by a one-way analysis of variance. When differences were indicated by the ANOVA, a comparison of treated vs. control groups was done using a Dunnett’s t-test. The alpha level at which all tests were conducted was 0.05.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: See table below. For the 5% and 25% group no significant response was observed. For the 100% group, the radioactivity count was increased about 4 fold. A SI of 4.4 was calculated. EC3 was calculated to be 70%.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table below
Any other information on results incl. tables
Results of the local lymph node assay (mean ± sd)
Concentration |
DPM |
SI |
Solvent control |
550.50 ± 351.43 |
1.0 ±0.6 |
5% |
546.83 ± 399.41 |
1.0 ± 0.6 |
25% |
494.17 ± 212.05 |
0.9 ± 0.4 |
100% |
2466.4 ± 803.88* |
4.4 ± 1.4 |
Positive control |
4073.8 ± 1325.3* |
7.4 ± 2.4 |
* statistically different; α = 0.05
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this LLNA, a positive response was only obtained after application of the highest dose (100% test substance). At this dose, local irritation reaction was observed. Test groups exposed to 5% and 25% test substance solution did not show any reaction. The 50% solution was not tested. Thus there is no information about an effect in the concentration range between 25% and 100% (additional value in dose-response-plot).
- Executive summary:
In a local lymph node assay with 2-methylbutyraldehyde (2-methylbutanal) (purity 98.2%), adult female CBA/J mice (6 animals per group) were tested using concentrations of 5, 25, and 100% test substance in vehicle (4:1 acetone/olive oil). Hexyl cinnamic aldehyde (30% in vehicle) was used as positive control material.
The positive control substance displays the appropriate response. For 2-methylbutyraldehyde, there was no effect of treatment on body weight development. Skin irritation, which resolved in all mice by day 6, was only observed on day 3 in mice dosed with 100% test substance (slight to well-defined erythema, 4 and 2 of 6 mice respectively). Increases in lymph cells were only observed in the 100% test group. For this group a SI of 4.4 was determined. EC3 was 70%.
In this study, 2-methylbutanal is a weak dermal sensitizer (categorized according to the expert ECETOC panel - Technical Report No. 87, 2003) (Dow 2008).
This study is classified as acceptable. It was performed according to OECD test guideline 429 with some restrictions (no individual caging, test substance concentrations were not in consecutive order).
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