Registration Dossier
Registration Dossier
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EC number: 274-324-8 | CAS number: 70131-50-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 19 April 2005 and 29 April 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed to GLP and internationally accepted guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bentonite, acid-leached
- EC Number:
- 274-324-8
- EC Name:
- Bentonite, acid-leached
- Cas Number:
- 70131-50-9
- Molecular formula:
- unspecified for this UVCB substance
- IUPAC Name:
- Bentonite, acid-leached
- Details on test material:
- - Name of test material (as cited in study report): Acid-activated bentonite
- Physical state: pale beige powder
- Lot/batch No.: TONSIL EX 0096
- Storage condition of test material: room temperature in the dark
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, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: Individually housed in suspended cages
- Diet: Free access to dertified rabbit diet (code 5322)
- Water: Free access to mains drinking water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17 to 23
- Humidity (%): 30 - 70
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g moistened with 0.5 mL of 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: Back of the rabbit
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch secured in position with a strip of surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize classification scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 42, 72 h
- Score:
- 0
- Irritant / corrosive response data:
- A single 4 hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. 3 minute and 1 hour semi-occluded applications of test material to the intact skin of one rabbit produced no evidence of skin irritation.
Any other information on results incl. tables
Table 1: pH of test material
Preparation |
pH measurement |
10% w/w aqueous preparation of test material |
approximately 3.8 |
Table 2: Individual skin reactions following four hour exposure
Skin reaction |
Observation time |
Individual scores – rabbit number and sex |
Total |
||
126 male |
117 male |
118 male |
|||
Erythema/Eschar formation |
1 h 24 h 48 h 72 h |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
( 0 ) 0 ( 0 ) 0 |
Oedema formation |
1 h 24 h 48 h 72 h |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
( 0 ) 0 ( 0 ) 0 |
Sum of 24 and 72 hour readings (S): 0 |
|||||
Primary irritation index (S/6): 0/6 |
|||||
Classification: NON-IRRITANT |
|||||
( ) = Total values not used for calculation of primary irritation index
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not considered to be irritating to skin according to CLP Regulation (EC) no. 1272/2008
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