Registration Dossier
Registration Dossier
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: 222-884-9 | CAS number: 3648-20-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Description of a well conducted human study reported in a peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of skin sensitization response of dialkyl (C6-C13) phthalate esters
- Author:
- Medeiros A M
- Year:
- 1 999
- Bibliographic source:
- Contact Dermatitis, 1999, 41, 287–289
Materials and methods
- Principles of method if other than guideline:
- - Principle of test:
DUP was tested in a 104 person panel human repeated insult patch test (HRIPT) using the modified Draize procedure
- Short description of test conditions: see below
- Parameters analysed / observed: see below - GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- An appropriate patch test in human is available which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- Diundecyl phthalate
- EC Number:
- 222-884-9
- EC Name:
- Diundecyl phthalate
- Cas Number:
- 3648-20-2
- Molecular formula:
- C30H50O4
- IUPAC Name:
- 1,2-diundecyl benzene-1,2-dicarboxylate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- N/A human study
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted DUP at 100% concentration
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted DUP at 100% concentration
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 104 male & female individuals
- Details on study design:
- RANGE FINDING TESTS: yes; irritation test in 14 female & 1 male subjects with undiluted DUP applied to a cotton pad covered by occlusive hypoallergenic tape. Responses evaluated 30 minutes & 24h after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9 applications
- Exposure period: a 24h contact period per application
- Test groups: 1
- Control group: no
- Site: deltoid area of the arm
- Frequency of applications: 3 X weekly (Monday, Wednesday & Friday) for 3 weeks
- Duration: 72h (reactions scored 48 or 72h after each induction application)
- Concentrations: 0.2 mL 100% undiluted DUP
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (following 10-17 day recovery period) in wk 6
- Day(s) of challenge: 1
- Exposure period: 24h
- Test groups: 1
- Control group: No
- Site: Naive site
- Concentrations: 0.2 mL 100% undiluted DUP
- Evaluation (hr after challenge): 48 & 96h - Challenge controls:
- not applicable
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 ml 100 % undiluted DUP
- No. with + reactions:
- 0
- Total no. in group:
- 104
- Clinical observations:
- none reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 0.2 ml 100 % undiluted DUP
- No. with + reactions:
- 0
- Total no. in group:
- 104
- Clinical observations:
- none reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- other: No data
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: No data
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- DUP was found without skin sensitization potential in a human repeated insult patch test (HRIPT).
- Executive summary:
Diundecyl phthalate was tested in a 104-person panel human repeated insult patch test (HRIPT) using the modified Draize procedure. Undiluted 100% DUP was used for the induction and challenge phases based upon a 24-h occluded irritation test on 15 panelists. The induction phase consisted in 9 applications of the test material to the same site, with a contact period of 24 h per application, and the challenge phase consisted in 1 application of 24 h to a naive site located away from the application site. Under the conditions of this HRIPT, no evidence of dermal irritation or sensitization was observed in the 104-person panel. These HRIPT data provide evidence for the lack of experimental skin sensitization potential for DUP in humans.
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.
