Registration Dossier
Registration Dossier
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EC number: 207-329-0 | CAS number: 462-94-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- Justification for type of information:
- No data
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The test guideline is not available in source test.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test guideline is not available in source test.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route)
Challenge: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route) - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route)
Challenge: aqueous solution of 2% hexamethylene diamine (epicutaneous route) and 1% (intradermal route) - No. of animals per dose:
- 10
- Details on study design:
- No additional data
- Challenge controls:
- No data
- Positive control substance(s):
- no
- Positive control results:
- No data
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Hexamethylene Diamine (HMD) at 2% and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Hexamethylene Diamine (HMD) at 2% and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Hexamethylene Diamine (HMD) at 2% and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Interpretation of results:
- GHS criteria not met
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 948
- Report date:
- 1948
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The aim of this study was to determine the sensitisation of Hexamethylene Diamine (HMD) with skin tests on Guinea Pigs. Two skin tests were performed. Firstly, a contact test with undiluted compound was performed, and secondly, a contact and sensitisation test was performed with a 2% aqueous solution of HMD, applied on skin with an initial patch and then with a final patch. For the contact and sensitisation test, a final injection was given to each rat after the customary ten-day rest period.
For all tests effects of HMD were analysed. - GLP compliance:
- no
- Type of study:
- other: study performed before GLP statement
Test material
- Reference substance name:
- Hexamethylenediamine
- EC Number:
- 204-679-6
- EC Name:
- Hexamethylenediamine
- Cas Number:
- 124-09-4
- Molecular formula:
- C6H16N2
- IUPAC Name:
- hexane-1,6-diamine
- Details on test material:
- - Name of test material (as cited in study report): Hexamethylene diamine
- Physical state: No data
- Analytical purity: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Hexamethylene Diamine (HMD) at 2% and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
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.
