Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 203-527-6 | CAS number: 107-86-8
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.
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.
