Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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

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.