Registration Dossier
Registration Dossier
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EC number: 248-660-0 | CAS number: 27794-93-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.05.2000 to 18.05.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [nitrilotris(methylene)]trisphosphonic acid, potassium salt
- EC Number:
- 248-660-0
- EC Name:
- [nitrilotris(methylene)]trisphosphonic acid, potassium salt
- Cas Number:
- 27794-93-0
- Molecular formula:
- C3H12NO9P3.xK
- IUPAC Name:
- potassium hydrogen {[bis(phosphonomethyl)amino]methyl}phosphonate
- Details on test material:
- - Name of test material (as cited in study report): Dequest 2004A
- Substance type: phosphonic acid (potassium salt)
- Physical state: Clear slightly yellow liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN.
- Age at study initiation: 'Adult'
- Weight at study initiation: 2.435 - 2.676 kg
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 47-64
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:15.05.2000 to 18.05.2000
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: No data
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: four hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.08
- Max. score:
- 8
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No edema observed at any time point.
- Irritant / corrosive response data:
- Very slight erythema on 4/6 test sites at the one hour scoring interval. The irritation was resolved by 48 hours.
- Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In a skin irritation study (reliability score 1) conducted to OECD 404 and GLP, potassium salt of ATMP was not irritating to the skin of rabbits.
- Executive summary:
In a skin irritation study (reliability score 1) conducted to OECD 404 and GLP, potassium salt of was not irritating to the skin of rabbits.
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