Registration Dossier
Registration Dossier
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EC number: 239-289-5 | CAS number: 15245-12-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles. However, since the study was performed with a substance analogue and the data are read across, the Klimisch score is 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF (2000) including recent revisions
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium
- EC Number:
- 231-119-8
- EC Name:
- Potassium
- Cas Number:
- 7440-09-7
- Molecular formula:
- K
- IUPAC Name:
- potassium
- Reference substance name:
- Calcium
- EC Number:
- 231-179-5
- EC Name:
- Calcium
- Cas Number:
- 7440-70-2
- Molecular formula:
- Ca
- IUPAC Name:
- calcium
- Reference substance name:
- Ammonium nitrogen
- IUPAC Name:
- Ammonium nitrogen
- Reference substance name:
- Nitrate nitrogen
- IUPAC Name:
- Nitrate nitrogen
- Test material form:
- solid: granular
- Details on test material:
- - Name of test material (as cited in study report): Nitcal/K
- Physical appearance: White granules
- Storage conditions: at room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 31-58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 January 2007 To: 26 January 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 grams
The test material was moistened with 0.4 ml of water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours after removal of dressings
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 150 square cm
- % coverage: not indicated
- Type of wrap if used: metalline patch applied to the skin of one flank wrapped around the abdomen and secured with elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring system for erythema and eschar formation (0-4) and for oedema formation (0-4)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No skin irritation was seen.
- Other effects:
- No symptoms of systemic toxicity, no mortality was seen.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of a skin irritation study in rabbits, Nitcal/K does not have to be classified or labelled for skin irritation according to Regulation (EC) 1272/2008 and under GHS.
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