Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 January to 09 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.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Luminova

IUPAC Name:

Luminova

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: 4 to 7 weeks
- Weight at study initiation: 111 to 125 g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: Metal cages with wire mesh floors
- Diet: Biosure LAD 1, ad libitum
- Water: ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70% R.H.
- Air changes (per hr): 10 to 15
- Photoperiod: 12 hr of artifical light, 0700 - 1900h

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% w/v
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

No. of animals per sex per dose:

Preliminary sighting study: 1 (female)
Main study: 5 (male)
Main study: 5 (female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: At least twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Preliminary study:

Species/strain: Rat, Sprague-Dawley 500 mg/kg bw: Evident toxicity: ; Mortality: N mg/kg bw: Evident toxicity: ; Mortality: Observations: The preliminary study indicated that the acute lethal oral dose to female rats of LumiNova was greater than 0.5 g/kg bodyweight.

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 5

Mortality:

None

Clinical signs:

other: Signs of toxicity: Piloerection was observed in all rats within five minutes of dosing and was persistent in all animals throughout Day 1 and Day 2. Recovery of all rats, as judged by external appearance and behaviour, was complete by the morning of D

Gross pathology:

Effects on organs:
Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The discriminating dosage of LumiNova when administered orally to rats was established to be greater than 2000 mg/kg bw.