1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

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:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

EC Number:

271-089-3

EC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Cas Number:

68515-47-9

Molecular formula:

C34H58O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich diisotridecyl Phthalate

Details on test material:

- Name of test material (as cited in study report): Jayflex DTDP-Z
- Chemical name: Di-isotridecyl phthalate
- Physical state: clear colorless liquid
- Analytical purity: minimum 99.6% ester content
- Lot/batch No.: VE 9/94
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Number used: 40 female
- Source: D. Hall, Staffordshire, England
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 290 - 357 kg
- Housing: groups of 5
- Diet (e.g. ad libitum): - Vitamin C enriched guinea pig diet ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

As supplied by Exxon Chemical International Inc.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

As supplied by Exxon Chemical International Inc.

No. of animals per dose:

20

Details on study design:

A. INDUCTION EXPOSURE
- No. of exposures: 3 induction exposures; day 1, 8 and 15
- Exposure period: 24 h
- Site: left shoulder region
- Frequency of applications: 1
- Concentrations: as supplied
- Evaluation (after induction): 30 minutes, 24 h

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14
- Exposure period: 6 h
- Site: right flank
- Concentrations: as supplied
- Evaluation (after challenge): 24, 48 and 72 h post patch removal

SCORING OF RESULTS
0 = No erythema
1 = Slight erythema
2 = Well-defined erythema
3 = Moderate erythema
4 = Severe erythema

Challenge controls:

Treated in a similar fashion as described but without the test compound.

Positive control substance(s):

yes

Remarks:

formalin

Study design: in vivo (LLNA)

Statistics:

No statistics provided.

Results and discussion

Positive control results:

Formalin produced a positive skin sensitization reaction in > 90 % of test animals.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 ml

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

0.5 ml

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 20.0.

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 20 test animals.

Executive summary:

In this study, 20 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 20 x 20 mm patch of surgical gauze was saturated with approximately 0.5 ml of test material was placed on the skin and covered by an impermeable plastic adhesive tape. 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 1, 8, and 15. The challenge application was given topically two weeks after the induction via the same method and scored for dermal reactions 24, 48 and 72 hours post exposure. In all cases, DTDP did not produce any dermal reactions.