Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic)

Endpoint summary

Description of key information

Acute oral toxicity > 2000 mg / kg bw

Acute dermal toxicity > 2000 mg /kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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:

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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:

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,

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1

Justification for classification or non-classification

On the basis of the acute toxicity results, LumiNova G will not be classified.