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Toxicological information

Skin irritation / corrosion

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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:
2005
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

Constituent 1
Chemical structure
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

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