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EC number: 203-527-6 | CAS number: 107-86-8
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.6
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-methyl-2-butenal
- EC Number:
- 203-527-6
- EC Name:
- 3-methyl-2-butenal
- Cas Number:
- 107-86-8
- Molecular formula:
- C5H8O
- IUPAC Name:
- 3-methyl-2-butenal
- Details on test material:
- - Name of test material (as cited in study report): 3-Methyl-2-butenal, CAS: 107-86-8; Substance-No. 90/734
- Physical state: liquid, achromatic
- Analytical purity: 96.3%
- Lot/batch No.: 90/11
- Storage condition of test material: room temperature under nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co KG
- Weight at study initiation: 300-350 g
- Housing: 5 per cage type IV Macrolon
- Diet: Kliba 341.4 mm rabbit-guinea pig laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.2% intradermal, 10% epicutaneous (induction); 5% (challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.2% intradermal, 10% epicutaneous (induction); 5% (challenge)
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irritant concentration was found to be a 10 % test substance preparation in aqua bidest, and the maximum nonirritant concentration a 5% test substance preparation in aqua bidest. (48 hours after the beginning of application).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 intradermal injections in groups of two per animal (Freunds adjuvant alone, 0.1 mt test substance alone, Freunds adjuvant plus test substance); percutaneous induction (one week after intradermal injections): 2x4 cm filter paper strips containing 0.3g of the test substance formulation
- Exposure period: 24 hrs
- Test groups: 10
- Control group: 5 (left untreated)
- Site: shoulder
- Frequency of applications:
- Duration: 24 hrs (intradermal); 48 hrs (percutaneous)
- Concentrations: 0.3 g per patch (filter papers were soaked with test substance); intradermal: 0.2%; percutaneous: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 hrs
- Test groups: 2 x2 cm filter paper strips applied under occlusive conditions
- Control group: group 1: receiving test substance formulation (5%); group 2: left untreated
- Site: flank skin at non-irritant concentration (5%)
- Evaluation (hr after challenge): 24, 48 hrs after removal of the patch
EVALUATION: The evaluation "sensitizing" results if at least 30 % of the experiment animals exhibit skin reactions - Challenge controls:
- Untreated animals and animals challenged with 5% of test substance in aqua bidest in previously NaCl or Freund's adjuvant treated animals
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitro-benzol (historical control)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in aqua dest.
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- one animal died 8 days after beginning of application
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in aqua dest.. No with. + reactions: 3.0. Total no. in groups: 9.0. Clinical observations: one animal died 8 days after beginning of application.
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Mortalities: One animal of the test group was found dead on day 8 after application.
Skin effects: (1) Well defined erythema and slight edema were seen
at the injection sites of Freund's complete adjuvans
(FCA)/saline (1:1) in both test and control animals.
Well defined erythema and slight edema were also
seen at the injection sites of the test substance in
FCA/saline in test animals. (2) Well defined erythema, slight edema and incrustation
(partially open from interadermal injections) were noted
after percutaneous induction in the test animals. (3) Positive skin reactions, i.e. erythema,
were observed in 3/9 test animals after the challenge
procedure at both readings. No reaction (0/5 animals)
was seen in the control group.
The positive control substance led to
positive skin reactions (erythema) in 10/10 animals
at both readings after
the challenge
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
24 h |
1 |
0 |
0 |
|
2 |
2 |
0 |
||
3 |
2 |
0 |
||
4 |
- |
- |
Exitus, April 3 1991 |
|
5 |
0 |
0 |
||
6 |
0 |
0 |
||
7 |
0 |
0 |
||
8 |
1 |
0 |
||
9 |
0 |
0 |
||
10 |
0 |
0 |
||
48 h |
1 |
0 |
0 |
|
2 |
1 |
0 |
||
3 |
2 |
0 |
||
4 |
- |
- |
Exitus, April 3 1991 |
|
5 |
0 |
0 |
||
6 |
0 |
0 |
||
7 |
0 |
0 |
||
8 |
1 |
0 |
||
9 |
0 |
0 |
||
10 |
0 |
0 |
||
Mean 24, 48 h |
1 |
0 |
0 |
|
2 |
1.5 |
0 |
||
3 |
2 |
0 |
||
4 |
- |
- |
Exitus, April 3 1991 |
|
5 |
0 |
0 |
||
6 |
0 |
0 |
||
7 |
0 |
0 |
||
8 |
1 |
0 |
||
9 |
0 |
0 |
||
10 |
0 |
0 |
||
Mean 24, 48 h |
1-10 |
0.5 |
0 |
Results of the control group: all animals were scored 0/0 for erythema/edema formation
Results of the test group: 3/9 positive (equal to 33.3%)
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- 3-methyl-2-butenal had a slight, borderline sensitizing
effect in the guinea pig maximation test.
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