Registration Dossier
Registration Dossier
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EC number: 604-102-1 | CAS number: 13893-53-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented an acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Robust Summary for Aminoalkylnitrile Category
- Author:
- US EPA HPVIS
- Year:
- 2 006
- Bibliographic source:
- Doc ID 201-16274
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- During the inductioin phase guinea pigs received a series of 4 sacral intradermal injections of 0.1 ml of a 1.0% solution in DMP, 1 each week beginning. After a 13 day rest period, challenge was performed with 0.05 ml of a 100% (as received) solution and a 10% solution of test substance in DMP on shaved, intact shoulder skin. At the same time 10 unexposed guinea pigs (controls) of the same age received identical topical applications.
- GLP compliance:
- no
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 2-amino-2-methylbutyronitrile
- EC Number:
- 224-752-6
- EC Name:
- 2-amino-2-methylbutyronitrile
- Cas Number:
- 4475-95-0
- IUPAC Name:
- 2-amino-2-methylbutanenitrile
- Reference substance name:
- Butanenitrile, 2-amino-2-methyl-
- IUPAC Name:
- Butanenitrile, 2-amino-2-methyl-
- Details on test material:
- Purity: 80%
yellow liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: dimethylphthalate (DMP)
- Concentration / amount:
- Induction: 1.0% solution in DMP (0.1 mL)
Challenge: 100% solution and a 10% solution of test substance in DMP (0.05 mL)
Challengeopen allclose all
- Route:
- other: epicutaneous, no information on coverage.
- Vehicle:
- other: dimethylphthalate (DMP)
- Concentration / amount:
- Induction: 1.0% solution in DMP (0.1 mL)
Challenge: 100% solution and a 10% solution of test substance in DMP (0.05 mL)
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 10-100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 10-100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
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.
