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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

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:
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.

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

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