Registration Dossier
Registration Dossier
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EC number: 202-088-8 | CAS number: 91-66-7
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:
- secondary literature
- Justification for type of information:
- Data is from authoritative database
Data source
Referenceopen allclose all
- Reference Type:
- other: Authoritative database
- Title:
- Determination of skin sensitization Potential of test chemical
- Author:
- IFA GESTIS
- Year:
- 2 018
- Bibliographic source:
- GESTIS Substance Database, 2018
- Reference Type:
- secondary source
- Title:
- SCREENING-LEVEL HAZARD CHARACTERIZATION Monocyclic Aromatic Amines Category
- Author:
- U.S. Environmental Protection Agency Hazard Characterization Document
- Year:
- 2 009
- Bibliographic source:
- U.S. Environmental Protection Agency Hazard Characterization Document. September,2009
- Reference Type:
- other: Secondary source
- Title:
- Skin sensitization study
- Author:
- IUCLID Dataset
- Year:
- 2 000
- Bibliographic source:
- EUROPEAN COMMISSION – European Chemicals Bureau; 19–FEB–2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization test was conducted on guinea pigs to assess skin sensitization potential of test chemical.
- GLP compliance:
- no
- Type of study:
- not specified
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- N,N-diethylaniline
- EC Number:
- 202-088-8
- EC Name:
- N,N-diethylaniline
- Cas Number:
- 91-66-7
- Molecular formula:
- C10H15N
- IUPAC Name:
- N,N-diethylaniline
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzenamine, N,N-diethyl-
- Molecular formula (if other than submission substance): C10-H15-N
- Molecular weight (if other than submission substance): 149.236 g/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- 10%
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- 1or 2%
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- No data available.
- Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- Concentrations: 10%
B. CHALLENGE EXPOSURE
- Concentrations: 1or 2%
-
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 1or 2%
- No. with + reactions:
- 0
- Clinical observations:
- No sensitization observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test material was considered to be not sensitizing on guinea pig skin.
- Executive summary:
The skin sensitization study was conducted in guinea pigs to observe the skin sensitization effects of test chemical.
In this study, the test animals were treated dermally with 10% solution of test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of test chemical .
Since the test animals failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.
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