Registration Dossier

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:
1999

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
Name:
Unnamed
Type:
Constituent
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

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 group
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 group
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.