Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
