Registration Dossier
Registration Dossier
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EC number: 931-210-9 | CAS number: 1266534-73-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Nov - 02 Dec 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Secrétariat général du GIPC - DGCIS - Si - 12, rue Villiot, 75572 Paris cedex 12, France
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- silicon(4+) dialuminium(3+) antimony nickel vanadium pentaoxidandiide
- EC Number:
- 931-210-9
- Cas Number:
- 1266534-73-9
- Molecular formula:
- (M2/nO*Al2O3*ySiO2*wH2O)x*(Ti,Sb,Ni,V O2)z*(Al2O3)k*(Al2Si2O7)l n is the valency of the cation M, predominantly Na, and for Na is n=1; y can range from 2 to 222; w can range from 0 to 30; x can range from 0.2 to 0.7; z can range from 0.01 to 0.05; k can range from 0.03 to 0.39; l can range from 0.26 to 0.39
- IUPAC Name:
- silicon(4+) dialuminium(3+) antimony nickel vanadium pentaoxidandiide
- Details on test material:
- - Name of test material (as cited in study report): LOOP
- Chemical name: Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony
- Analytical purity: 99%
- Lot/batch No.: 09303322/1
- Production date: 30 Jun 2009
- Expiration date of the lot/batch: 29 Jun 2011
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER, 53940 Le Genest St Isle, France
- Age at study initiation: male: 7 weeks, females: 8 weeks
- Weight at study initiation: male: 225-239 g, female: 198-218 g
- Housing: during treatment, the animals were kept in individual cages, at day 3 in groups of two or three, in solid-bottomed clear polycarbonate cages
- Diet (e.g. ad libitum): M20, SDS (rat/mouse maintenance)
- Water (e.g. ad libitum): tap water from public distribution
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: fur was removed from the dorsal area of the trunk of the test animals approx. 24 h before treatment
- % coverage: at least 10% of the body surface area (i.e. 25 cm2)
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with olive oil
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL/kg body weight
- For solids, paste formed: yes, 8 g in 20 mL liquid paraffin (grey homogenous suspension)
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed daily; animals were weighed just before substance administration and then on days 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Current control study:
- acording to OECD 402
- study period: 04 Aug - 18 Aug 2009
- test item: liquid paraffin
- 10 animals (5 male, 5 female), topical application of 10 mL/kg bw under porous gauze dressing, during 24 h
- results: Clinical examinations: nothing to report; Body weight evolution: normal during the test; Necrospy: no treatment related changes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality observed during the study.
- Clinical signs:
- other: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
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