Registration Dossier
Registration Dossier
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EC number: 700-697-8 | CAS number: 264145-26-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 17 January to 16 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:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- the test was made before the entry into force of Annex VII.
Test material
- 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.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Laboratory animal supplier
- Age at study initiation: four to five weeks
- Weight at study initiation: 292 to 336 g
- Housing: Groups of five in metal cages with wire mesh floors
- Diet: Vitamin c enriched guinea-pig diet FD1 ad libitum
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx 15
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Concentration of test material and vehicle used at induction: Intradermal injection: 7.5% w/v in Alembicol D.
Topical application: 70% w/v in Alembicol D. Concentration of test material and vehicle used for each challenge: Topical challenge: 70% and 35% w/v in Alembicol D.
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Concentration of test material and vehicle used at induction: Intradermal injection: 7.5% w/v in Alembicol D.
Topical application: 70% w/v in Alembicol D. Concentration of test material and vehicle used for each challenge: Topical challenge: 70% and 35% w/v in Alembicol D.
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 3
- Control group: Yes
- Site: Scapular region
- Frequency of applications:
- Duration: 48 hours
- Concentrations: Intradermal 7.5% w/v, Topical 70% w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 3
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site:Anterior and posterior flanks.
- Concentrations: 35 and 70% w/v in Alembicol D.
- Evaluation (hr after challenge): 24, 48 and 72 hours.
OTHER: - Challenge controls:
- The control animals were challenged topically two weeks after the topical induction application using LumiNova, 70 and 35% w/v in Alembicol D.
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- 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.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 70 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 35 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 70 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 35 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 70 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 35 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 70 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 35 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 35 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
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
|
|
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 sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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