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EC number: 231-830-3 | CAS number: 7758-02-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Sodium bromide
- EC Number:
- 231-599-9
- EC Name:
- Sodium bromide
- Cas Number:
- 7647-15-6
- IUPAC Name:
- sodium bromide
- Details on test material:
- - Name of test material (as cited in study report): Sodium Bromide, technical grade
- Description: white powder
- Analytical purity: 99.23 %
- Lot/batch No.: 7320
- Other:
preparation of test substance: a) for induction: 7.5% and 30% in water (intradermal and topical); b) for challenge: 5% and 10% in water (topical)
Potassium bromide is an inorganic salt that dissociates to its composite ions in aqueous solutions at environmental pH and temperature. Comparison of the available data on the various bromide salts have shown that the bromide ion is the relevant ion for determination of the toxicological profile with simple cations such as potassium, sodium or ammonium, that are ubiquitous in nature, having little or no influence on the bromide ion properties. It is therefore justified to read-across data from other inorganic bromide salts to potassium bromide.
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: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: Not indicated
- Weight at study initiation: 301-374g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction:
7.5% w/w sodium bromide, technical grade in water (intradermal injection)
30% w/w sodium bromide, technical grade in water (topical application)
Challenge:
5% and 10% w/w sodium bromide, technical grade in water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction:
7.5% w/w sodium bromide, technical grade in water (intradermal injection)
30% w/w sodium bromide, technical grade in water (topical application)
Challenge:
5% and 10% w/w sodium bromide, technical grade in water
- No. of animals per dose:
- 20 in test group
20 in control group - Details on study design:
- RANGE FINDING TESTS:
The irritancy of a range of dilutions following intradermal and topical application was investigated for the selection of suitable irritant concentrations for induction and non-irritant concentrations for challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two
- Exposure period: day 0 intradermal injection, day 7 topical application
- Site: scapular region
- Duration: 24 h for topical application
- Concentrations: 7.5% w/w sodium bromide, technical grade in water (intradermal injection), 30% w/w sodium bromide, technical grade in water (topical application)
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: day 21
- Exposure period: 24 hours
- Site: scapular region
- Concentrations: 5% and 10% w/w sodium bromide, technical grade in water
- Evaluation (hr after challenge): 24h, 48h and 72h after challenge
OTHER:
Concentration Freunds Complete Adjuvant (FCA): 50% in water - Positive control substance(s):
- yes
- Remarks:
- Formalin
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 7.5 % / 30 %, 10 % / 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5 % / 30 %, 10 % / 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 7.5 % / 30 %, 10 % / 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5 % / 30 %, 10 % / 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs .
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs .
Any other information on results incl. tables
Result of pilot study:
Intradermal injection of different concentrations of sodium bromide resulted in slight to mild oedema and slight to necrotic erythema (see table 6.1.5/02-1).
Topical application of 5, 10, 20 and 30 % sodium bromide, technical grade showed localized dermal reactions in one of the animals treated with 20% of test substance. This reaction was reversible and skin appeared normal by 24 hours after treatment. All other animals did not show reactions after treatment.
Based on the results of the preliminary investigations, concentrations of 7.5% (w/w) and 30% (w/w) were selected for intradermal and topical induction and 10% and 5% (w/w) for topical challenge application.
Overall result of main study:
Sodium bromide, technical grade did not produce evidence of delayed contact hypersensitivity
Table A6.1.5/02-1 Results of pre-test with Sodium Bromide, technical grade, intradermal injection
|
||||||
Guinea-pig number |
Concentration [% w/w]
|
|
Score |
|
||
|
1 |
2 |
|
|||
4674/4679 |
10 |
D E O |
8/12 N/N 2/2 |
8/10 N/N 2/2 |
|
|
7.5 |
D E O |
8/10 2/2 1/1 |
8/10 1/1 1/1 |
|
||
5 |
D E O |
6/8 2/2 1/1 |
6/6 1/1 2/2 |
|
||
2.5 |
D E O |
6/6 2/2 1/1 |
6/6 1/1 1/1 |
|
||
1 |
D E O |
4/4 1/1 1/1 |
4/4 1/1 1/1 |
|
||
0.5 |
D E O |
4/4 1/1 1/1 |
4/4 1/1 1/1 |
|
||
0.25 |
D E O |
4/4 1/1 1/1 |
4/4 1/1 1/1 |
|
||
0.1 |
D E O |
4/4 1/1 1/1 |
4/4 1/1 1/1 |
|
||
vehicle control (water) |
D E O |
4/4 1/1 1/1 |
4/4 1/1 1/1 |
|
||
D: Diameter (mm)
E: Erythema (0-4 numerical scores)
O: Oedema (0-4 numerical scores)
N: Necrosis
1: score assessed day of injection
2: score assessed day 3 after injection
Table A6.1.5/02-2 Results of main study with Sodium Bromide, technical grade, challenge application
Treatment |
Guinea-pig number |
Erythema (E) Oedema (O) |
Score |
Results |
|||||
24 h |
48 h |
72 h |
|||||||
A |
P |
A |
P |
A |
P |
||||
Freund´s Treated control |
5590 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
5591 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5592 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5593 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5594 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5595 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5596 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5597 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5598 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5599 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5560 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5501 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5502 |
E O |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5503 |
E O |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5504 |
E O |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5505 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5506 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5507 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5508 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
5509 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
n.d. |
|
Test |
5510 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
5511 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5512 |
E O |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5513 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5514 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5515 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5516 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5517 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5518 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5519 |
E O |
0 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5520 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5521 |
E O |
L1 0 |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5522 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5523 |
E O |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5524 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5525 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5526 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5527 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5528 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5529 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
A Anterior site, exposed to 10% w/w sodium bromide, technical grade in distilled water
P Posterior site, exposed to 5% w/w sodium bromide, technical grade in distilled water
L1 Localized dermal reaction, restricted to a small area of the challenge site
Results: + positive
- negative
+/- inconclusive
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this screening test performed with twenty guinea pigs, sodium bromide, technical grade did not produce evidence of delayed contact hypersensitivity. The test substance does not have to be classified and labelled with respect to skin sensitisation.
- Executive summary:
Materials and Methods
The study was designed to assess skin sensitisation potential of Sodium Bromide, technical grade. The intradermal and topical irritancy of a range of dilutions of sodium bromide, technical grade was investigated to identify (a) irritant test substance concentrations suitable for the induction phase of the main study and (b) non-irritant concentrations by the topical route of administration for the challenge phase. Based on the results of this preliminary investigation concentrations of sodium bromide for the main study were selected. For the main study twenty guinea pigs were treated with the test substance intracutaneously (day 0) and epicutaneously (day 7) for induction and epicutaneously (day 21) for challenge.
Results and Discussion
The dermal reactions seen in the test animals are similar to those seen in the control animals.
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