Registration Dossier
Registration Dossier
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EC number: 232-160-4 | CAS number: 7789-38-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 25 - September 15, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Potassium bromate
- EC Number:
- 231-829-8
- EC Name:
- Potassium bromate
- Cas Number:
- 7758-01-2
- Molecular formula:
- BrHO3.K
- IUPAC Name:
- potassium bromate
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% Lutrol® F 68 in water
- Concentration:
- 1.25, 2.5, 7.5 %
- No. of animals per dose:
- Total 20 animals
3 test groups with 4 animals
1 negative control group with 4 animals (vehicle control)
1 positive control group with 4 animals (20% -alpha-Hexylcinnamaldehyde, tech. 85%) - Details on study design:
- according to guideline
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- Experiment performed in May 2010.
Positive control substance: 2-Hexylcinnamaldehyde
Vehicle: acetone:olive oil (4+1)
Test item concentration % (w/v) Group Measurement DPM Calculation Result
DPM-BG a) number of lymph nodes DPM per lymph node b) S.I.
--- BG I 13 --- --- --- ---
--- BG II 12 --- --- --- ---
0 1 4561 4549 8 568.6 1.00
5 2 9275 9263 8 1157.8 2.04
10 3 15507 15495 8 1936.8 3.41
25 4 27961 27949 8 3493.6 6.14
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4 = Test Group
S.I. = Stimulation Index
a) = The mean value was taken from the Sgures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 1.25% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 0.53
- Test group / Remarks:
- 2.5% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 0.64
- Test group / Remarks:
- 7.5% (w/v)
Any other information on results incl. tables
The EC3 value could not be calculated, since all S.I.´s are below 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, potassium bromate was not a skin sensitizer.
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