Registration Dossier
Registration Dossier
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EC number: 275-735-5 | CAS number: 71630-92-7 Substance obtained by burning the husk removed from the rice paddy. Contains silica as well as the elements aluminum, calcium, carbon, chromium, copper, indium, iron, lead, magnesium, manganese, molybdenum, phosphorus, silver, sodium, tin, and zinc.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Apr 2010 - 13 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Ashes (residues), rice husk
- EC Number:
- 275-735-5
- EC Name:
- Ashes (residues), rice husk
- Cas Number:
- 71630-92-7
- Molecular formula:
- SiO2
- IUPAC Name:
- silanedione
- Details on test material:
- - Name of test material (as cited in study report): Rice husk ash
- Physical state: crystalline black powder
- Analytical purity: >80%
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 4-5 weeks
- Weight at study initiation: 310-370 g
- Housing: The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Altromin 3122 maintenance diet for guinea pigs(lot no. 1047), rich in crude fiber and autoclaved hay; ad libitum
- Water (e.g. ad libitum): tap water (drinking water, municipal residue control, microbiol. controlled periodically); ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- Vaseline, Riedel-de Haen, lot no. 72360, expiry date: 28/02/2012
- Concentration / amount:
- 25% (w/w) in Vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- Vaseline, Riedel-de Haen, lot no. 72360, expiry date: 28/02/2012
- Concentration / amount:
- 25% (w/w) in Vaseline
- No. of animals per dose:
- Preliminary test: 2
Test group: 20
Negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: A solubility test was performed which showed that the highest applicable concentration of the test-item in vaseline was 25%.
The appropriate concentrations for the induction and challenge exposures were determined by preliminary tests with different concentrations. For this purpose two animals were topically treated with a concentration of 25% and 12.5% for approximately 6 hours.
Neither erythema nor oedema were recorded for any of the animals. 24 as well as 48 hours after the patch removal, one of the two animals showed scratches at the application site after both the treatment with the 25% and 12.5% concentration.
Based on the results of these preliminary tests, a concentration of 25% was chosen for the inductions and the challenge applications.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Test substance in Vaseline
- Control group: Vaseline only
- Site: left flank
- Frequency of applications: weekly
- Duration: 3 weeks
- Concentrations: 0 (control) and 25% in Vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction application
- Exposure period: 6 h
- Test groups: Test substance in Vaseline and Vaseline only
- Control group: Test substance in Vaseline and Vaseline only
- Site: test substcance on the right flank, Vaseline on the left flank
- Concentrations: 0 and 25% in Vaseline
- Evaluation (hr after challenge): 24 and 48
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 1 animal showed scratches at the application site.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 1 animal showed scratches at the application site..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 3 animals showed scratches at the application site.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 3 animals showed scratches at the application site..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 3 animals showed scratches at the application site.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 3 animals showed scratches at the application site..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 2 animals showed scratches at the application site.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 2 animals showed scratches at the application site..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 7 animals showed scratches at the application site. Thereof, one animal showed eschar.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 7 animals showed scratches at the application site. Thereof, one animal showed eschar..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 2 animals showed scratches at the application site.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 2 animals showed scratches at the application site..
Any other information on results incl. tables
Main Test
Induction readings: No signs of irritation were observed in any of the animals after the inductions.
Challenge readings: The results of the test animals at the challenge phase were compared to the results of the control animals (for results, see Tables 3 and 4).
4 out of 20 test animals and 3 out of 10 control animals showed scratches at the application site after treatment with the test item. 8 out of 20 test animals showed scratches at the application site after treatment with the vehicle. 1 out of 20 test animals showed scratches and eschar at the application site after treatment with the vehicle. No other treatment related effects were observed.
The maximum percentage of animals sensitised was 0 %.
Animals of both groups survived throughout the test period. No signs of toxicity were recorded. The animals of the test group showed neither reduced weight gain compared to historical data nor compared to the animals of the control group.
Table 3:Summary:Grading of Reactions after Challenge in Comparison toControl Animals.
|
E0 |
E1 |
E2 |
E3 |
O0 |
O1 |
O2 |
O3 |
Animals sensitised% |
T24h |
20 |
-- |
-- |
-- |
20 |
-- |
-- |
-- |
0 |
T48h |
20 |
-- |
-- |
-- |
20 |
-- |
-- |
-- |
0 |
C24h |
10 |
-- |
-- |
-- |
10 |
-- |
-- |
-- |
0 |
C48h |
10 |
-- |
-- |
-- |
10 |
-- |
-- |
-- |
0 |
E = Erythema O = Oedema 0 - 3 = Grade
T = Test group C = Control group
24h, 48h hours after end of challenge treatment
Table 4:Individual:Grading of Reactions after Challenge in Comparison to Control Animals.
Animal No. |
Conc.%Item |
Erythema 24 hours |
Oedema 24 hours |
Erythema 48 hours |
Oedema 48 hours |
T1 |
25 |
0 ts |
0 |
0 |
0 |
T2 |
25 |
0 |
0 |
0 |
0 |
T3 |
25 |
0 |
0 |
0 |
0 |
T4 |
25 |
0 |
0 |
0 |
0 |
T5 |
25 |
0 |
0 |
0 vs |
0 |
T6 |
25 |
0 vs |
0 |
0 |
0 |
T7 |
25 |
0 |
0 |
0 |
0 |
T8 |
25 |
0 |
0 |
0 |
0 |
T9 |
25 |
0 |
0 |
0 vs |
0 |
T10 |
25 |
0 |
0 |
0 |
0 |
T11 |
25 |
0 |
0 |
0 vs |
0 |
T12 |
25 |
0 |
0 |
0 vs / e |
0 |
T13 |
25 |
0 |
0 |
0 vs |
0 |
T14 |
25 |
0 |
0 |
0 |
0 |
T15 |
25 |
0 ts |
0 |
0 ts |
0 |
T16 |
25 |
0 vs |
0 |
0 |
0 |
T17 |
25 |
0 |
0 |
0 |
0 |
T18 |
25 |
0 |
0 |
0 vs |
0 |
T19 |
25 |
0 ts |
0 |
0 |
0 |
T20 |
25 |
0 vs |
0 |
0 ts / vs |
0 |
C1 |
25 |
0 |
0 |
0 |
0 |
C2 |
25 |
0 ts |
0 |
0 ts |
0 |
C3 |
25 |
0 |
0 |
0 ts |
0 |
C4 |
25 |
0 |
0 |
0 |
0 |
C5 |
25 |
0 |
0 |
0 |
0 |
C6 |
25 |
0 |
0 |
0 |
0 |
C7 |
25 |
0 |
0 |
0 |
0 |
C8 |
25 |
0 |
0 |
0 |
0 |
C9 |
25 |
0 |
0 |
0 |
0 |
C10 |
25 |
0 |
0 |
0 |
0 |
ts = scratches at the application site after treatment with the test item vs = scratches at the application site after treatment with the vehicle e = eschar |
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Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, the test item Rice husk ash caused no reactions identified as sensitisation at the tested concentration. The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
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