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EC number: 215-175-0 | CAS number: 1309-64-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2005-07-18 to 2005-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- , EC Guideline B.6. (96/54/EC)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- old study - old standard for skin sensitisation testing
Test material
- Reference substance name:
- Diantimony trioxide
- EC Number:
- 215-175-0
- EC Name:
- Diantimony trioxide
- Cas Number:
- 1309-64-4
- Molecular formula:
- Sb2O3
- IUPAC Name:
- oxostibanyl stibinate
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: supplier: Charles River Deutschland GmbH
- Age at study initiation: 29 days
- Weight at study initiation: 266 - 306 g (positive reference group: 310 - 381 g)
- Housing: MAKROLON cages (type III plus), granulated textured wood (bedding material)
- Diet (e.g. ad libitum): ssniff Ms-H V2233 (ssniff Spezialitäten GmbH) ad libitum
- Water (e.g. ad libitum): tap water in drinking bottles (ad libitum)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C±3°C
- Humidity (%): 55 % ± 15 %
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h light
IN-LIFE DATES: From: To: 2005-08-26
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- test group:
- Stage 1 intracutaneous: 10 % (w/w) suspension of Antimony trioxide in aqua ad iniectabilia (induction)
- Stage 2 topical: 50 % (w/w) suspension of Antimony trioxide in aqua ad iniectabilia (induction)
- Stage 3 topical: 50 % (w/w) suspension of Antimony trioxide in aqua ad iniectabilia (challenge) - Day(s)/duration:
- 48h
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- test group:
- Stage 1 intracutaneous: 10 % (w/w) suspension of Antimony trioxide in aqua ad iniectabilia (induction)
- Stage 2 topical: 50 % (w/w) suspension of Antimony trioxide in aqua ad iniectabilia (induction)
- Stage 3 topical: 50 % (w/w) suspension of Antimony trioxide in aqua ad iniectabilia (challenge)
- No. of animals per dose:
- - in-test group: 20 animals
- vehicle control group (negative control): 10 animals
- positive control group: 20 animals (historical background, July 2005)
- preliminary study group: 8 animals - Details on study design:
- RANGE FINDING TESTS:
PRELIMINARY STUDY
- 8 animals
- determination of intracutaneous administration: ∙ concentrations of 0.001, 0.01 and 0.1 % of test substrate (0.1 ml each) were injected into the
shoulder region of one test animal
∙ concentrations of 1, 5 and 10 % of test substrate were injected in a second animal
- determination of topical administration: ∙ 3 animals - each shaved or shaved and depilated
∙ 2 ml of test substance preparation was spread over a filter paper
∙ 2 concentrations each of 0.5, 1, 5, 10, 25 and 50 % of test substrate were applied
∙ occlusive dressing
∙ removal of filter papers after 24 or 48 h
∙ assessing sites for erythema and oedema (0 h, 24 h and, at depilated sites 48 h, after removal)
- results: no skin reactions were observed
--> the of 10 % antimony trioxide for intracutaneous, and 50 % for topical administration in the main study
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intracutaneous (stage 1) + topical (stage 2))
- Exposure period: 48 h (stage 2l)
- Test groups: ∙ 3 pairs of injections (0.1 ml each); 1) a 1:1 mixture (v/v) Freund's complete adjuvant (FCA) :0.9 % NACl
2) 10% suspension of antimony in water
3) a 1:1 mixture (v/v) of antimony suspension : FCA / 0.9 % NACl (= 10 % antimony)
∙ 1 sodium lauryl sulfate (10%, 0,5 ml) coating on same area 6 days after injection, as skin is not irritated from injection
∙ 1 topical exposure of 2 ml of a 50 % suspension of antimony on the same region 7 days after injection
- Control group: ∙ negative control: vehicle control group treated with aqua ad iniectabilia in the same way as test group
∙ positive control: treated with 2 % (w/v) benzocaine solution intracutaneous; 5 % (w/v) benzocaine solution topical
- Site: shoulder region (cleared of hair)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 topical exposure (stage 3)
- Day(s) of challenge: 21 days after injection
- Exposure period: 24 h
- Test groups: ∙ L flank - 2 ml of a 50 % suspension of antimony; R flank - vehicle aqua ad iniectabilia
- Control group: ∙ negative control: vehicle control; L flank - 50 % suspension of antimony; R flank - vehicle aqua ad iniectabilia
∙ positive control: 5 % (w/v) benzocaine solution
- Site: flank region (cleared of hair)
- Concentrations: 2 ml of a 50 % (w/w) suspension in vehicle
- Evaluation (hr after challenge): 48 hr and 72 hr
OTHER: - Challenge controls:
- no
- Positive control substance(s):
- yes
- Remarks:
- benzocaine
Results and discussion
- Positive control results:
- No positive control group was tested concurrently in this study. A positive historical background data group from a study performed July 2005 in the same laboratory.
- 11 cases of discrete or patchy erythema and 9 cases of confluent erythema in a 20 animals group
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle only (0 %)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle only (0 %). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- vehicle only (0%)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: vehicle only (0%). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 ml of a 50 % (w/w) suspension in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 ml of a 50 % (w/w) suspension in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2 ml of a 50 % (w/w) suspension in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2 ml of a 50 % (w/w) suspension in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% (w/v) benzocaine in 40 % ethanolic 0.9 % NaCl solution
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema (in 11 cases) and confluent erythema (in 9 cases)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5% (w/v) benzocaine in 40 % ethanolic 0.9 % NaCl solution. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema (in 11 cases) and confluent erythema (in 9 cases).
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 5 % (w/v) benzocaine in 40 % ethanolic 0.9 % NaCl solution
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema (in 11 cases) and confluent erythema (in 9 cases)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 5 % (w/v) benzocaine in 40 % ethanolic 0.9 % NaCl solution. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema (in 11 cases) and confluent erythema (in 9 cases).
Any other information on results incl. tables
- no animal
was found dead
- body weight gain of the animals treated with Antimony trioxide was
within the range of the vehicle control group
- behavior of the animals treated with Antimony trioxide remained
unchanged
- topical induction was not irritating to the non-depilated skin
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- This study shows that diantimony trioxide does not have sensitising properties.
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