Registration Dossier
Registration Dossier
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EC number: 664-406-5 | CAS number: 277319-62-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The study report is not available for the applicant, but the data source and the available endpoints are sufficient to justify at least a precautionary classification.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-amino-N-hydroxybenzene-1-carboximidamide
- EC Number:
- 664-406-5
- Cas Number:
- 277319-62-7
- Molecular formula:
- C7 H9 N3 O
- IUPAC Name:
- 4-amino-N-hydroxybenzene-1-carboximidamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: group K (negative control) 1.0 group A (low dose) 6.5 group B (mid dose) 6.0 group C (high dose) 5.2 group P (positive control) 7.9
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: group K (negative control) 3012 group A (low dose) 19568 group B (mid dose) 18222 group C (high dose) 15599 group P (positive control) 23859
Any other information on results incl. tables
Additionally to the endpoint informations in a safety data sheet, the following details were submitted by the
data sheet supplier:
Results of the LNAA-Test:
4-Aminobenzamidoxim
dpm SI
group K (negative control) 3012 1.0
group A (low dose) 19568 6.5
group B (mid dose) 18222 6.0
group C (high dose) 15599 5.2
group P (positive control) 23859 7.9
The substance has to be classified as sensitizing (SI>3).
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information cat. 1A Criteria used for interpretation of results: EU
- Conclusions:
- Based on the datas the substance has to be classified according to EU 1272/2008 (CLP-regulation) as skin sens 1A.
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.
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