Registration Dossier
Registration Dossier
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EC number: 222-884-9 | CAS number: 3648-20-2
Endpoint summary
Administrative data
Description of key information
Key study: Human repeated insult patch test (HRIPT) using the modified Draize procedure (Medeiros A M, 1999). DUP was found not to be a sensitizer for human skin.
Data waiving: In accordance with column 2 of REACH Annex VII, an in vitro skin sensitization study does not need to be conducted since an in vivo study on skin sensitisation is available.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
- 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.
- Species:
- other: Human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- N/A human study
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted DUP at 100% concentration
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
- 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
- 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
- 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.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, the study does not need to be conducted since an in vivo study on skin sensitisation is available.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key study: 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.
Data waiving: In accordance with column 2 of REACH Annex VII, an in vitro skin sensitization study does not need to be conducted since an in vivo study on skin sensitisation is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the substance does not need to be classified for skin sensitization according to CLP Regulation (EC) no. 1272/2008.
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