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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 January to 14 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.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
416-840-1
EC Name:
-
Cas Number:
201426-52-0
Molecular formula:
Al2 O4 .Dy0.02 .Eu0.01 .Sr0.97
IUPAC Name:
dioxo-2,4-dioxa-1,5-dialumina-3-strontapentane dysprosium europium
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.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Laboratory animal supplier
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 219 to 258 g
- Fasting period before study: no data
- Housing: Metal cages with wire mesh floors
- Diet: Biosure LAD 1 ad libitum
- Water: ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70% R.H.
- Air changes (per hr): 10 - 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 50 x 50 mm
- % coverage: approximately 10%
- Type of wrap if used: Gauze held in place with a non-irritative dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm (30° to 40°C) water and blotted dry with absorbent paper.
Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g / kg bw
- Concentration (if solution): 166.67 % w/v
- Constant volume or concentration used: yes
- For solids, paste formed: no data

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.2 mg / kg bw
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 h
Doses:
2000 mg / kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mornings and afternoons.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology,

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: There were no clinical signs of systemic reaction to treatment.
Gross pathology:
Effects on organs: No abnormalities were recorded at the macroscopic examination on day 15
Other findings:
Signs of toxicity (local): Sites of application of LumiNova showed no irritation or other dermal changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dose to rats of LumiNova was found to be greater than 2000 mg / kg bw.