Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-928-2 | CAS number: 14075-53-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guildeline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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:
- Potassium tetrafluoroborate
- EC Number:
- 237-928-2
- EC Name:
- Potassium tetrafluoroborate
- Cas Number:
- 14075-53-7
- Molecular formula:
- BF4.K
- IUPAC Name:
- potassium tetrafluoroborate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): potassium tetrafluoroborate
- Physical state: white crystalline solid
- Lot/batch No.: 2281A
- 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: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: ca. 12-16 weeks
- Weight at study initiation: 2.57-2.70 kg
- Housing: individually in suspended metal cages
- Diet: Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K., ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 52-63
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): moistened wth 0.5 mL distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- % coverage: 100
- Type of wrap if used: elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well-defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating to the skin.
- Executive summary:
In a GLP-compliant OECD guideline 404 study, rabbits were exposed to potassium tetrafluoroborate to determine skin irritating properties. 0.5 g of the test substance moistened with 0.5 mL distilled water were applied under semi-occlusive conditions to the skin of 3 rabbits for 4 hours. After the removal of the patches animals were observed for 72 hours. No evidence of skin irritation was noted (erythema and edema scores were 0 at all time points (24, 48 and 72 hours) in all animals). Based on the results of the study, potassium tetrafluoroborate is considered to be not irritating to skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
