Registration Dossier
Registration Dossier
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EC number: 287-401-6 | CAS number: 85507-79-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Descrition of a well conducted human study reported in a peer reviewed journal. For read-across justification see Section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- DUP was tested in a 104 person panel human repeated insult patch test (HRIPT) using the modified Draize procedure.
- GLP compliance:
- not specified
- Remarks:
- Not applicable
- Type of study:
- other: Human repeated insult patch test
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:
- diundecyl benzene-1,2-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): diundecyl phthalate
- Physical state: liquid
- Analytical purity: >99.0 % based on product specification for DUP
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- N/A human study
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted DUP at 100% concentration
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted DUP at 100% concentration
- 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 hypoallergenic tape. Responses evaluated 30 minutes & 24h after patch removal
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9, with a 24h contact period on each occasion
- Exposure period: a 24h contact period on each occasion
- Test groups: 1
- Control group: no
- Site: deltoid area of the arm
- Frequency of applications: 3 X weekly (Monday, Wednesday & Fri) for 3 weeks
- Duration: 72h (reactions scored 48 or 72h after each induction application)
- Concentrations: 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: No
- Control group: No
- Site: Naive site
- Concentrations: 0.2 ml 100% undiluted DUP
- Evaluation (hr after challenge): 48 & 96h - Challenge controls:
- None
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Statistics:
- No data
Results and discussion
- Positive control results:
- N/A
In vivo (non-LLNA)
Resultsopen allclose all
- 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:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml 100 % undiluted DUP. No with. + reactions: 0.0. Total no. in groups: 104.0. Clinical observations: None reported.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. Dose level: 0.2 ml 100 % undiluted DUP. No with. + reactions: 0.0. Total no. in groups: 104.0. Clinical observations: None reported.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this HRIPT< following treatment with undiluted 100% DUP, there was no evidence of skin irritation (dose range finding study) or sensitisation (main study) in any of the 104 panelists who completed the study.
- Executive summary:
A human repeat insult patch test (HRIP) with the undiluted substance resulted in no evidence of sensitisation in any of the 104 panelists who completed the study.
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