Registration Dossier
Registration Dossier
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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.
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