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Toxicological information

Acute Toxicity: dermal

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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:
Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic)
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:
Signs of toxicity related to dose levels: There were no clinical signs of systemic reaction to treatment.
Body weight:
Slightly low bodyweight gains were recorded for two males and one female on Day 8 and for four males on day 15. In addition, one female showed a slight bodyweight loss on Day 8. These changes were considered likely to reflect the trauma of the treatment procedure rather than being directly related to the test substance. All other animals achieved satisfactory body weight gains throughtout the study.
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.

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