Registration Dossier
Registration Dossier
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EC number: 700-282-1 | CAS number: 66922-99-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Aug 2010 - 16 Sep 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health of the Government of the United Kingdom 2009
- Test type:
- standard acute method
- Limit test:
- yes
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Oxon, UK.
- Strain: HsdRddHan®TM:WIST®TM
- Age at study initiation: 8-12 weeks of age
- Weight at study initiation: males: 324-362 g, females 200-228 g
- Fasting period before study:
- Housing: in suspended solid-floor polypropylene cages furnished with woodflakes; individually during the 24-h exposure period and in groups of up to four, by sex, for the remainder of the study.
- Diet (ad libitum): 2014 Teklad Global Rodent diet by Harlan Laboratories
- Water:ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: Surgical gauze and self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
After the 24-hour contact period the bandage was removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test item.
TEST MATERIAL
The test item was weighed out according to each animal's individual body weight and moistened with distilled water prior to application.
The absorption of the test item was not determined.
VEHICLE
distilled water - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2 and 4 hours after dosing and subsequently once a day
- Frequency of weighing: on days 0, 7 and 14
- Necropsy of survivors performed: yes, including external examination and opening of the abdominal and thoracic cavities.
- Other examinations performed: daily skin examination for irritation according to Draize system for 14 days.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity and no signs of dermal irritation.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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