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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 238-056-5 | CAS number: 14205-39-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Methyl 3-aminocrotonate
- EC Number:
- 238-056-5
- EC Name:
- Methyl 3-aminocrotonate
- Cas Number:
- 14205-39-1
- Molecular formula:
- C5 H9 O2 N
- IUPAC Name:
- methyl 3-aminocrotonate
- Details on test material:
- Beta-Aminocrotonsäuremethylester, white solid, purity 99.5%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 12% (= 60 mg test substance/animal)
First and second challenge: 1% (= 5 mg test substance/animal)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 12% (= 60 mg test substance/animal)
First and second challenge: 1% (= 5 mg test substance/animal)
- No. of animals per dose:
- control group. 5
test substance group: 10
range-finding group: 2
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Challenge 1%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: Challenge 1%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Group:
- test chemical
- Dose level:
- Challenge 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. Group: test group. Dose level: Challenge 1%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Group:
- negative control
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. Group: negative control. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: none.
Any other information on results incl. tables
Appearance and behaviour of the test substance group were not different from the control groups. At the end of the study, the body weight development of the treatment group animals corresponded to that of the control group animals.
The incidence of skin reactions (number of animals exhibiting skin effects) following the challenge is summarized in the following table:
| Test substance group (10 animals) | Control group (5 animals) | |||||||||
| Test substance patch | Control patch | Test substance patch | Control patch | |||||||
| Hours | 48 | 72 | total | 48 | 72 | 48 | 72 | total | 48 | 72 |
| 1. Challenge 1% | 3 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2. Challenge 1% | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 1 |
Applicant's summary and conclusion
- Executive summary:
To determine the skin-sensitizing properties of methyl 3 -aminocrotonate the guinea pig maximization test was performed on female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:
intradermal induction: 5%
topical induction: 12%
first and second challenge: 1%
Under the condition of the maximization test and with respect to the evaluation criteria methyl 3 -aminocrotonate exhibited no skin-sensitization potential.
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.
