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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
European Union Risk Assessment Report - Diantimony Trioxide
Author:
European Chemicals Agency (ECHA)
Year:
2008
Bibliographic source:
European Union Risk Assessment Report - Diantimony Trioxide, may 2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin sensitization study of Diantimony Trioxide was performed in guinea pig by Magnusson and Kligman method
GLP compliance:
not specified
Type of study:
other: Magnusson and Kligman method
Justification for non-LLNA method:
No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diantimony Trioxide
- Molecular formula : O3Sb2
- Molecular weight : 291.51g/mole
- Substance type: inorganic
- Physical state: crystalline powder
- Purity: 99.93
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report): Diantimony Trioxide
- Molecular formula : O3Sb2
- Molecular weight : 291.51g/mole
- Substance type: inorganic
- Physical state: crystalline powder
- Purity: 99.93
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
0.1ml of 10% concentration in water for intradermal and 50% concentration in water for epicutaneous application
Day(s)/duration:
48hr
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
50% concentration in water for epicutaneous application
Day(s)/duration:
24hr
No. of animals per dose:
Total :30
Treated group:20
Control group:10
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period: 48hr
- Test groups:20
- Control group:10
- Site: shoulder

- Frequency of applications: on day 1st and 7th
- Duration: 48hr

- Concentrations: 1)10%
2) 50%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: After 21 days

- Exposure period: 24hr

- Test groups:20
- Control group:10
- Site: left flank

- Concentrations: 50% suspension in water
- Evaluation (hr after challenge): 21hr


OTHER : 6 days after the intracutaneous injection, the exposed skin was coated with 0.5 ml sodium lauryl sulphate 10 % in vaseline in order to induce a local irritation
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
21
Group:
test group
Dose level:
50% concentration in water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin sensitizing reaction was observed
Remarks on result:
no indication of skin sensitisation
Remarks:
No skin sensitizing reaction was observed

Any other information on results incl. tables

A preliminary study was done

Applicant's summary and conclusion

Interpretation of results:
other: Not Sensitizing
Remarks:
skin sensitizing reaction was not observed
Conclusions:
The skin sensitization study of Diantimony Trioxide (1309-64-4) was performed by Magnusson and Kligman method was considered to be not skin sensitizing in guinea pig.
Executive summary:

The skin sensitization study of Diantimony Trioxide (1309-64-4)was performed byMagnusson and Kligman methodin20guinea pigs.An additional 10 animals served as the control group. A preliminary study with 8 animals was performed to determine the appropriate dose level for intracutaneous and topical administration

 In induction phase,3 pairs of intradermal injections (0.1 ml each); 1) a 1:1 mixture (v/v) of Freund’s complete adjuvant (FCA):0.9 % NaCl. 2) 10 % suspension of diantimony trioxide in water and 3) a 1:1 mixture (v/v) of diantimony trioxide suspension: FCA/ 0.9 % NaCl resulting in a final concentration of diantimony trioxide of 10 % were given in shoulder region. After 6 day,the exposed skin was coated with 0.5 ml sodium lauryl sulphate 10 % in vaseline in order to induce a local irritation then second induction using 50% concentration in water as suspension applied as patch for 48hr in same site as shoulder region.

 In challenge phase, after 21 days on left flank region 50% suspension of test material in water was applied as patch for 24hr. After 21hr treated skin cleaned and evaluated for skin sensitization reaction.No indication of skin sensitization was observed.Hence it is considered that Diantimony Trioxide (1309-64-4)was not skin sensitizing in guinea pig by Magnusson and Kligman method