Registration Dossier
Registration Dossier
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EC number: 235-183-8 | CAS number: 12124-97-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-07-01 to 1986-07-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- Six female rabbits were used for the study and observed up to 72-hours post-exposure only
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Six female rabbits were used for the study and observed up to 72-hours post-exposure only
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium bromide
- EC Number:
- 235-183-8
- EC Name:
- Ammonium bromide
- Cas Number:
- 12124-97-9
- Molecular formula:
- BrH4N
- IUPAC Name:
- Bromide activated chloramine (BAC) generated from ammonium bromide and sodium hypochlorite
- Details on test material:
- - Name of test material (as cited in study report): Ammonium Bromide
- Description: White crystalline powder
- Analytical purity: not applicable
- Lot/batch No.: LRSI No. 091358186, Batch No. 5230
- Stability under test conditions: test material is considered to have remained stable under the storage conditions
- Storage condition of test material: material was kept at ambient temperature, in the original container
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: three months
- Weight at study initiation: 2.16-3.06 kg
- Housing: Individually in suspended steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 1986-07-01 To: 1986-07-04
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right test site of each animal was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/animal - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 x 6 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle wash with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Scoring system as given in OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable; no erythema formation.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable; no oedema formation
- Other effects:
- none
Any other information on results incl. tables
Table A6.1.4/01-1 Results of skin irritation study |
|||
score (average animals investigated) |
time |
Erythema |
Edema |
average score |
60 min |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
average score |
24h, 48h, 72h |
0 |
0 |
reversibility: * |
- |
- |
|
average time for reversibility |
- |
- |
|
* c : completely reversible |
|||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test Ammonium Bromide was designated `non-irritant` to skin. In accordance with CLP Regulation (EC) No 1272/2008, no classification and labelling with respect to dermal irritation is required.
- Executive summary:
Materials and Methods
The objective was to asses the potential of Ammonium Bromide to cause inflammatory or corrosive changes upon first contact with skin. A quantity of 0.5 g of test material was applied semi-occluded to six New Zealand White Rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings.
Results and Discussion
No dermal irritation responses were observed in any animal at any reading time point during the observation period.
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