Tetradecaaluminium tetrastrontium pentacosaoxide, dysprosium and europium doped

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

24 January to 09 February 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

LumiNova G and LumiNova BG are both inorganic substances comprising of > 99% aluminium strontium oxide but in slightly different proportions, they are both doped with dysprosium and europium and have negligible impurities. They are therefore considered to be very similar in physical and chemical characteristics and suitable for using in a one-to-one scenario.

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:

LumiNova G and LumiNova BG are both inorganic substances comprising of > 99% aluminium strontium oxide but in slightly different proportions, they are both doped with dysprosium and europium and have negligible impurities. They are therefore considered to be very similar in physical and chemical characteristics and suitable for using in a one-to-one scenario.

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.

Any other information on results incl. tables

Study	Result for LumiNova BG (Target chemical)	Result for LumiNova G (Source chemical)	Notes
Physical appearance	Inorganic light yellowish green powder	Inorganic phosphorescent yellow powder
Melting point	Waived	Waived	In accordance with Column 2 adaptation statement of REACH Annex VII, Information requirement section 7.2, this study does not need to be conducted below a lower limit of -20°C.
Boiling point	Waived	Waived	The study is not needed for solids which melt above 300°C or decompose before boiling and has been omitted in accordance with Column 2 of Annex VII Section 7.3 of the REACH regulation.
Density	RD = 3.6	RD = 3.63
Particle size	25.9%   =< 10.4µm 74.1% =< 30µm	3.51%  <=  2.00 µm 21.40 % <= 10.1 µm 99.51%  <= 203.3µm
Vapour pressure	Waived	Waived	In accordance with Column 2 adaptation statement of REACH Annex VII, information requirement section 7.5, this study does not need to be conducted if the melting point is >300°C
Partition coefficient	0	< 0 at 20°C	Read-across
Water solubility	88.0 mg/l	300 mg/l at 20°C
Surface tension	72 mN/m	69.9 mN/m
Flash point	Waived	Waived	Flash point is a property relevant to liquids and low melting point solids and so is waived in accordance with Section 2 of annex XI of the REACH regulation.
Auto flammability	Waived	Waived	Undertaking this study is unjustified because the test substance is inorganic with a melting point > 1300°C.
Flammability	Waived	Waived	Undertaking this study is unjustified because the test substance is inorganic with a melting point > 1300°C.
Explosiveness	Waived	Waived	In accordance with Column 2 adaptation statement of REACH Annex VII, information requirement section 7.11, this study does not need to be conducted based on a structural assessment of the substance. Examination of the structure indicates that there are no groups associated with explosive properties.
Oxidising properties	Not oxidising	Not oxidising
Biodegradation in water	Waived	Waived	In accordance with column 2 of REACH annex VII, this study does not need to be conducted if the substance is inorganic.
Acute toxicity to Daphnia	48h EC50 = 13mg/l	48h EC50 = 13 mg/l	Read-across
Acute toxicity to algae	72h EC50 = 29 mg/l	72h EC50 = 29 mg/l	Read-across
Acute oral toxicity	Discriminating dose > 2000 mg/kg bw	Discriminating dose > 2000 mg/kg bw	Read-across
Skin irritation	Not irritating	Not irritating
Eye irritation	Not irritating	Not irritating
Skin sensitisation	Not sensitising	Not sensitising	Read-across
Genetic toxicity - Ames	Not mutagenic	Not mutagenic

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU