Diisodecyl azelate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

16 Sep - 25 Oct 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

other: report on study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Marzulli and Maibach method

Deviations:

yes

Remarks:

no volume of the applied substance specified

GLP compliance:

not specified

Remarks:

GCP

Test material

Test material information

Constituent 1

Reference substance name:

Diisopropyl sebacate

EC Number:

231-306-4

EC Name:

Diisopropyl sebacate

Cas Number:

7491-02-3

Molecular formula:

C16H30O4

IUPAC Name:

diisopropyl sebacate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: 100%
- LOT: 02060013

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 55, however only 51 subjects were available at study termination.
- Sex: 13 male, 42 female
- Age: 18-69 years

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: other immunological tests: Marzulli and Maibach Method

ADMINISTRATION
- Type of application: For induction, occlusive exposure for 48 hours, three times a week for three weeks on the back was performed. After a two week recovery period, a challenge exposure was performed under an occlusive dressing for 48 h either on the same site as the induction or another site that had never had contact with the test substance.
- Description of patch: occlusive strip with Flexcon(TruMed Technologies Inc., Burnsville, Minnesota)
- Vehicle / solvent: no
- Concentrations: undiluted test substance (100%)
- Volume applied: no data

EXAMINATIONS
- Grading/Scoring system: see table 1

- Other: After each induction exposure, cutaneous reactions were evaluated directly as well as 24 and 48 h after patch removal.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: No significant reaction attributable to sensitisation was observed in the 51 volunteers finishing the study.


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 51 (not all subjects finished study up to challenge)
- Number of subjects with irritating reactions: 0/53 (not all subjects continued study up to induction)

Any other information on results incl. tables

Table 2: Subjects with positive reactions at the study stages

Study stage	Subjects with positive reactions/all subjects*
Induction day 1	0/53
Induction day 2	0/53
Induction day 3	0/52
Induction day 4	0/51
Induction day 5	0/51
Induction day 6	0/51
Induction day 7	0/51
Induction day 8	0/51
Induction day 9	1/50**
48h after challenge	0/51
72h after challenge	0/50
96h after challenge	0/48

* The number of subjects changed during the study because of subjects that didn't continue the study or subjects that were not present at single observation days.

** None of the subjects showed any sensitisation to the test material and only one showed slight irritation (+) at day 9 of induction. The test material at 100% when applied to the human skin is not irritating and not sensitising.

Applicant's summary and conclusion

Conclusions:

In a study with human volunteers the test substance did not show a skin sensitisation potential.