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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 611-624-3 | CAS number: 581076-67-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3. february 2003 - 7. march 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented and reported study, conducted according to internationally accepted technical guideline. A GLP compliance statement and a Quality Assurance Statement is included in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Modified according to Maurer & Hess
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- N-(3-Guanidino-4-methyl-phenyl)-4-(4-methyl-piperazin-1-ylmethyl)-benzamide, dihydrochloride
- Cas Number:
- 581076-67-7
- Molecular formula:
- Hill formula: C21 H30 Cl2 N6 O CAS formula: C21 H28 N6 O.2Cl H
- IUPAC Name:
- N-(3-Guanidino-4-methyl-phenyl)-4-(4-methyl-piperazin-1-ylmethyl)-benzamide, dihydrochloride
- Details on test material:
- Batch No.: 022401
expiration date: december 2003
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- white petrolatum was used as vehicle for the challenge exposure
- Concentration / amount:
- 50 % (w/v) in white petrolatum for the first induction exposure
50 % (w/v) in white petrolatum for the second induction exposure
50 % (w/v) in white petrolatum for the challenge exposure
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- physiological saline
- Remarks:
- white petrolatum was used as vehicle for the challenge exposure
- Concentration / amount:
- 50 % (w/v) in white petrolatum for the first induction exposure
50 % (w/v) in white petrolatum for the second induction exposure
50 % (w/v) in white petrolatum for the challenge exposure
- No. of animals per dose:
- 10 animals for the test substance group
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- all animals had severe erythema and oedema in the interscapular region (scor 3).
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% (w/w). No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: all animals had severe erythema and oedema in the interscapular region (scor 3)..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 10.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results of this study and to the REGULATION (EC) No 1272/2008, the test substance needs to be labelled as a sensitizer,Category 1.
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.
