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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: This study is rated a "1" because it applied GLP, used appropriate testing procedures, and followed an accepted test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Jayflex DIUP, Di-isoundecyl phthalate

- Physical state: Clear oily colorless liquid (to light yellow)
- Analytical purity: 99.7% minimum ester content

- Lot/batch No.: Batch No. VE67/94
- Expiration date of the lot/batch: 5 July 1995

- 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
- Source: D Hall, Newchurch, Staffordshire, England
- Age at study initiation: 6-7 wks
- Weight at study initiation: 291-340 g
- Housing: Groups of 5 in suspended metal cages with wire floors
- Diet: ad libitum, vitamin C enriched guinea pig diet FD1. Hay was given weekly.
- Water: ad libitum
- Acclimation period: 12 days


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


IN-LIFE DATES: From: July 14, 1994 To: August 26, 1994

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
100% undiluted
Challengeopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
100% undiluted
No. of animals per dose:
20 test and 20 control animals
Details on study design:
RANGE FINDING TESTS: The topical irritancy of a range of dilution of the test substance was investigated to identify where possible (a) concentrations that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration for the challenge phase. Based on the results of the preliminary investigations, the concentration of Jayflex DIUP was applied as supplied. From preliminary investigations administration of the test substance as supplied did not give rise to irritating effects.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 induction applications
- Exposure period: A 20 x 20 mm patch of surgical gauze was saturated with ~0.5 ml of Jayflex DIUP, as supplied. The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape. Contact with the skin was maintained for ~6 hours for each induction exposure. The dressings were then removed and the resulting dermal reactions assessed 24 hours later.
- Test groups: 1
- Control group: 1
- Site: skin on the left shoulder region, clipped free of hair
- Frequency of applications: Applications were made on days 1, 8, and 15

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: 50 x 50 mm area on the right flank
- Concentrations: As supplied
- Evaluation (hr after challenge): 24, 48, and 72 hours
Positive control substance(s):
yes
Remarks:
The sensitivity of the guinea pig strain used is checked periodically at Huntingdon Research Center with formalin, a known sensitizer. Most recent positive control data collected from Nov 15, 1993 to December 16, 1993.

Results and discussion

Positive control results:
The sensitivity of the guinea pig strain used is checked periodically at Huntingdon Research Center with formalin, a known sensitizer. Most recent positive control data collected from Nov 15, 1993 to December 16, 1993. Of the 10 test female guinea pigs, at a 30% aqueous dilution dose level, all 10 animals showed skin sensitization.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
as supplied (100%)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: as supplied (100%). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
as supplied (100%)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: as supplied (100%). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
as supplied (100%)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In this study, the test substance did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the twenty test animals.
Executive summary:

The study was performed to assess the skin sensitization potential of Jayflex DIUP using the guinea pig based on the EU method B.6 of directive 92/69/EEC and according to GLP. Based on the results of a preliminary study and in compliance with the guideline undiluted test substance was selected as the dose level. Twenty test and twenty control guinea-pigs were used. The test substance did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any of the twenty test animals. In addition, no sign of irritation was reported during the induction period.