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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: Acceptable, well-documented study report equivalent or similar to Directive 84/449EEC, B6: GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
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 DINP
- Substance type: liquid
- Physical state: clear colorless liquid

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 weeks
- Weight at study initiation: 281-341 g
- Housing: groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 days


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:
0.5 ml
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml
No. of animals per dose:
5
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Days 1, 8, and 15
- Test groups: 1
- Control group: 1
- Site: left shoulder region
- Exposure: 6 hours
- Frequency of applications: single
- Concentrations: 0.5 ml


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after the final induction
- Test groups: 1
- Control group: 1
- Site: right flank
- Concentrations: 0.5 ml
- Exposure: 6 hours
- Evaluation (hr after challenge): 24, 48 and 72 hours after exposure
Challenge controls:
Induction control - no test compound
Challenge control - test compound
Positive control substance(s):
yes
Remarks:
Test material

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
NA
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: 5.0. Clinical observations: NA.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5ml
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
NA
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5ml. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: NA.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

A Buehler test was carried out in forty female Guinea pigs (20 control and 20 treated animals) with Jayflex DINP (CAS 68515-48-0). The substance was applied neat (0.5 ml) for induction at day 1-8-15 during 6 hours under occlusive bandaging and for challenge at day 29. No evidence of skin sensitisation was observed in any of the treated animals. This test was conducted in conformity with GLP procedures and with EEC Method B6.