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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
Study period:
17 January to 16 February 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken at a GLP accredited laboratory, to internationally accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
the test was made before the entry into force of Annex VII.

Test material

Constituent 1
Reference substance name:
Luminova
IUPAC Name:
Luminova
Details on test material:
- Name of test material (as cited in study report): LumiNova
- Substance type: Luminous
- Physical state: Powder
- Analytical purity: 100% w/w
- Lot/batch No.: NR-003-1
- Expiration date of the lot/batch: May 1996
- Stability under test conditions:
- Storage condition of test material: In the dark at room temperature in dry conditions.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Laboratory animal supplier
- Age at study initiation: four to five weeks
- Weight at study initiation: 292 to 336 g
- Housing: Groups of five in metal cages with wire mesh floors
- Diet: Vitamin c enriched guinea-pig diet FD1 ad libitum
- Water: ad libitum
- Acclimation period: five days

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

IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Alembicol D
Concentration / amount:
Concentration of test material and vehicle used at induction: Intradermal injection: 7.5% w/v in Alembicol D.
Topical application: 70% w/v in Alembicol D. Concentration of test material and vehicle used for each challenge: Topical challenge: 70% and 35% w/v in Alembicol D.
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Alembicol D
Concentration / amount:
Concentration of test material and vehicle used at induction: Intradermal injection: 7.5% w/v in Alembicol D.
Topical application: 70% w/v in Alembicol D. Concentration of test material and vehicle used for each challenge: Topical challenge: 70% and 35% w/v in Alembicol D.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 3
- Control group: Yes
- Site: Scapular region
- Frequency of applications:
- Duration: 48 hours
- Concentrations: Intradermal 7.5% w/v, Topical 70% w/v

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 3
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site:Anterior and posterior flanks.
- Concentrations: 35 and 70% w/v in Alembicol D.
- Evaluation (hr after challenge): 24, 48 and 72 hours.

OTHER:
Challenge controls:
The control animals were challenged topically two weeks after the topical induction application using LumiNova, 70 and 35% w/v in Alembicol D.
Positive control substance(s):
yes
Remarks:
Hexyl cinnamic aldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
70 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
35 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
70 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
35 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
70 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
35 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
70 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
35 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 70 %

Signs of irritation during induction:
Intradermal injection: Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control
animals.  Slight irritation was seen in test animals at sites receiving LumiNova, 7.5% w/v in Alembicol D and slight
irritation was observed in control animals receiving Alembicol D alone.

Topical application:  Slight erythema was observed in test animals following topical application with LumiNova, 70% w/v
in Alembicol D and slight erythema was seen in the control guinea-pigs.

Evidence of sensitisation of each challenge concentration: None

Other observations: There were no dermal reactions seen in any of the test or control animals (isolated incidence of dryness and sloughing
was observed for two test animals).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study, LumiNova did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.

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