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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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.
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:
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.
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
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.

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).

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Migrated from Short description of key information:

In this study, LumiNova did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.

Justification for selection of skin sensitisation endpoint:

Study undertaken to GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result of the skin sensitisation study, LumiNova G will not be classified.