Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic)

Acute Toxicity: dermal

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

Test material information

Constituent 1

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.