Diisotridecyl phthalate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-03-14 to 1993-04-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Testing performed following Good Laboratory Guidelines (GLP).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

Diisotridecyl phthalate

EC Number:

248-368-3

EC Name:

Diisotridecyl phthalate

Cas Number:

27253-26-5

Molecular formula:

C34H58O4

IUPAC Name:

1,2-bis(2-methyldodecyl) benzene-1,2-dicarboxylate

Details on test material:

- Name of test material (as cited in study report): VESTINOL TD
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 99.6 % (v/v)
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: Diisotridecyl phthalate
- Purity test date: no data
- Lot/batch No.: not known
- Expiration date of the lot/batch: September 1993 at the earliest
- Stability under test conditions: not mentioned
- Storage condition of test material: in a closed container under hood
- Other: Date of production: 1992-09-21
Stability: > 1 year

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Dunkin Hartley, Pirbright White

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Winkelman, Borchen, Germany
- Age at study initiation: young adults, no further details mentioned
- Weight at study initiation: test group: 473 ± 22 g; control group: 469 ± 35 g (mean weights)
- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage)
- Diet: Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not mentioned (preliminary study)
not mentioned (main study)

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Induction 2

Concentration / amount:

induction: 100%
challenge: 100%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Challenge 2

Concentration / amount:

induction: 100%
challenge: 100%

No. of animals per dose:

test animals: 19 (main experiment), 4 (pilot study)
control animals: 10

Details on study design:

RANGE FINDING TESTS:
Determination of the non-irritant concentration of the test substance with occlusive epicutaneous applications for 6 hours of
test substance 40%, 60% and 80% in corn oil MEH 56 and 100% (undiluted). Readings directly after patch removal and 24
and 48 hours post application.


MAIN STUDY

A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: occlusive dermal applications for 6 hours, scoring at 6 and 24 hours after application
- Test group: receiving test substance (0.4 cm³/patch)
- Control group: receiving vehicle (0.4 cm³ corn oil/patch)
- Site: left flanks
- Frequency of applications: induction on days 0, 7 and 14
- Duration: 3 weeks
- Concentrations: 100% (undiluted) test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28
- Exposure period: occlusive dermal application for 6 hours
- Test groups: receiving test substance (0.4 cm³/patch)
- Control group: receiving test substance (0.4 cm³/patch)
- Site: right flanks
- Concentrations: 100 % (undiluted)
- Evaluation (hr after challenge): 6, 24, 48 and 72 hours post application

Challenge controls:

same treatment as test group animals

Positive control substance(s):

yes

Remarks:

1-chloro-2,4-dinitrobenzene

Results and discussion

Positive control results:

The responsivness of the used strain was tested at regular intervalls, no further details mentioned.

In vivo (non-LLNA)

Results

Results 1

Reading:

other: all time points (24, 48 and 72 hours p.a.)

Group:

test chemical

Dose level:

undiluted test substance

No. with + reactions:

0

Total no. in group:

19

Clinical observations:

No test substance related systemic effects or impairment of body weight gain were observed.

Remarks on result:

other: see Remark

Remarks:

Reading: other: all time points (24, 48 and 72 hours p.a.). Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: No test substance related systemic effects or impairment of body weight gain were observed..

Results 2

Reading:

other: all time points (24, 48 and 72 hours p.a.)

Group:

negative control

Dose level:

undiluted test substance

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other: all time points (24, 48 and 72 hours p.a.). Group: negative control. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

RESULTS OF PILOT STUDY: No irritant effects at any concentration of the test substance tested.

RESULTS OF TEST.

- Sensitisation reaction: No sensitising effects observed.

- Clinical signs: No clinical effects observed. Body weight increase comparable to control.

- Rechallenge: not performed

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material did not product evidence of skin sensitisation (delayed contact hypersensitivity) in any of the 19 test animals.

Executive summary:

In this study, 19 guinea pigs were exposed to DTDP in a skin sensitization exposure paradigm utilizing and induction and challenge phase in the method of the Buehler test. A patch was saturated with approximately 0.4 ml of test material was placed on the skin. Contact with the skin was maintained for approximately 6 hours. The dressings were then removed and the resulting dermal reactions assessed approximately 24 hours later. Inductions were conducted on days 0, 7, and 14. The challenge application was given topically 28days after the induction via the same method and scored for dermal reactions 6, 24, 48 and 72 hours post exposure. In all cases, DTDP did not produce any dermal reactions.