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Toxicological information

Skin sensitisation

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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

Constituent 1
Chemical structure
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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
As supplied by Exxon Chemical International Inc.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
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)

Resultsopen allclose all
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.
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.