Registration Dossier
Registration Dossier
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EC number: 700-282-1 | CAS number: 66922-99-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Aug 2010 - 20 Aug 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study Analytical purity not given, responsibility of the sponsor.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health of the Government of the United Kingdom 2009
Test material
- Reference substance name:
- tripotassium trihydrogen phosphate dihydrate
- EC Number:
- 700-282-1
- Cas Number:
- 66922-99-4
- Molecular formula:
- H304P.H20.3/2K
- IUPAC Name:
- tripotassium trihydrogen phosphate dihydrate
- Details on test material:
- - Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given; responsibility of the sponsor
- Batch number: 9086
- Expiry date: 23 Dec 2011
- Storage conditions: room temperature in the dark under nitrogen
- pH (10% w/w aqueous preparation of the test item): 6.5 - 6.6
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Loughborough, UK
- Strain: Hsdlf:NZW
- Age at study initiation: 2.30 or 2.24 kg
- Weight at study initiation: 12-20 weeks
- Housing: individually in suspended cages
- Diet (ad libitum): 2030 Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd. Oxon, UK
- Water:ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped using veterinary clippers
- Vehicle:
- water
- Controls:
- other: non-treated sites served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied: 0.5 mL distilled water - Duration of treatment / exposure:
- Animal #1: 3 minutes, 1 hour and 4 hours
Animal #2: 4 hours - Observation period:
- 72 hours
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank area
A 2.5 cm x 2.5 cm cotton gauze patch was used to apply 0.5 g of the test substance moistened sufficiently with 0.5 mL of distilled water.
- Type of wrap if used: Surgical adhesive tape and elasticated corset
REMOVAL OF TEST SUBSTANCE
Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.
SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 2 animals and mean of readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4-hour exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 2 animals and mean of readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4-hour exposure
Any other information on results incl. tables
3 -minute and 1 -hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation. A single 4 -hour, semi-occluded application of the test item to the intact skin of two rabbits produced no evidence of skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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