Registration Dossier
Registration Dossier
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EC number: 432-240-0 | CAS number: 12056-51-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 December 1989 to 31 January 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 432-240-0
- EC Name:
- -
- Cas Number:
- 12056-51-8
- Molecular formula:
- K2Ti6O13
- IUPAC Name:
- Potassium hexatitanate
- Details on test material:
- - Name of test material (as cited in study report): Potassium titanate fibre
- Substance type: Light yellow / green, fine powder.
- Physical state: Solid
- Analytical purity: 100% (Ti 47.5, K 13.5 (wt%))
- Lot/batch No.: A249
- 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: Male rabbits, from Japan SLC Co., Ltd., Koto-cho, Hamamatsu-shi, Shizuoka, Japan.
- Age at study initiation: Not reported.
- Weight at study initiation: 1.81 - 2.16 kg.
- Housing: Housed individually in a hanging stainless cage (35 X 50 X 35 cm: Toyo Riko k.k.)
- Diet (e.g. ad libitum): RC-4 (Oriental Yeast Industry k.k.), at libitum.
- Water (e.g. ad libitum): UV sterilised / filtred tap water, ad libitum.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2ºC.
- Humidity (%): 55 ± 10%.
- Air changes (per hr): 13 changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and 12 hours darkness.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: The test material as supplied was moistened with 0.5 ml of distilled water.
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 6 males.
- Details on study design:
- TEST SITE
- Area of exposure: 4 sites, area not specified, 1 inch square lint put on a moistureproof gum (approximately 4 X 4 cm)
- Type of wrap if used: elastic bandage and surgical tapes
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with slightly tepid water.
- Time after start of exposure: 4 hours.
SCORING SYSTEM:
The test sites were examined for evidence of primary irritation and scored according to the grading in the test guideline. The results were interpreted under EU classification system.
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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 days
- Other effects:
- Slight erythema (score 1) was observed in 3 out of 6 animals
at 1 hour only.
No significant changes in clinical signs were observed. No deaths occurred. There was no effects on body weight gain.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The primary skin irritation potential of potassium titanate of fibre was studied in rabbits according to the OECD Guidelines. The irritation response observed during the study period was only slight erythema (score 1) at 1 hour after tearing off the wraps and the reaction recovered (score 0) within 24 hours after tearing off the wraps. Therefore it was concluded that the skin irritation potential of the substance was quite minimal.
The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008). - Executive summary:
To assess the skin irritation potential of potassium titanate fiber a primary skin irritation study was conducted in rabbits in accordance with the OECD guidelines.
During the study the skin of 6 New Zealand White rabbits was exposed to 500 mg of test material moistened with 0.5 mL of distilled water, under occlusion, for a period of 4 hours.
Slight erythema (score 1) was observed in 3 out of 6 animals; all changes were fully reversible within 1 day.
It was concluded that the skin irritation potential of potassium titanate fibre was quite minimum.
The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
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