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Diss Factsheets

Administrative data

Description of key information

Skin irritation / corrosion; A single semi-occlusive application of LumiNova to intact rabbit skin for four hours elicited no dermal response.

Eye irritation; A single instillation of Luminova into the eye of the rabbit elicited dulling of the cornea and transient well-defined conjunctival irritation.  All reactions had resolved two days after instillation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 to 27 January 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Laboratory animal supplier
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.4 to 3.0 kg
- Housing: Individually in metal cages with perforated floors.
- Diet: SDS Stanrab (P) Rabbit Diet ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 19
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Vehicle:
other: Distilled water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
Approximatel 1, 24, 48 and 72 hours,
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 100 x 100 mm
- % coverage: no data
- Type of wrap if used: 25 x 25 mm gauze pad held by adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water (30° to 40 °C) to remove any residual test substance. The treated area was blotted dry with abosorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of LumiNova to intact rabbit skin for four hours elicited no dermal response.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 January to 13 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.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Laboratory animal supplier
- Age at study initiation: 11 to 14 weeks
- Weight at study initiation: 2.5 to 3.3 kg
- Housing: Individually in metal cages with perforated floors.
- Diet: SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: Yes but no data.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 19
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To:
Vehicle:
unchanged (no vehicle)
Controls:
other: No but the contralateral eye remained untreated.
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data-
- Time after start of exposure:

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand held lamp
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
Clinical signs: There were no signs of toxicity or ill health in any rabbit during the observation period.
Ocular responses: Dulling of the normal lustre of the cornea was seen one hour after instillation in all three animals. No iridial inflammation was observed. Hyperaemia or diffuse crimson colouration of the conjunctivae (maximum score of 2 in a single animal at one hour after instillation), accompanied by slight swelling of the eyelids was seen in all three animals. The reactions gradually ameliorated and the eyes were normal two days after instillation.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single instillation of Luminova into the eye of the rabbit elicited dulling of the cornea and transient well-defined conjunctival irritation.All reactions had resolved two days after instillation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:

Study undertaken to GLP.

Justification for selection of eye irritation endpoint:

Study undertaken to GLP.

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies, LumiNova G will not be classified.