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Toxicological information

Acute Toxicity: oral

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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

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:
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 Day 3.
Body weight:
All animals gained bodyweight during the study.
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.

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