Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Performed between 23 March 2010 and 06 April 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to GLP and internationally accepted guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

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):Bentonite acid-leached
- Physical state: Solid
- Lot/batch No.: not supplied
- Expiration date of the lot/batch: 31 December 2010
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: At least 200 g
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At lesat 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 30 to 70 %
- Air changes: 15 changes per hour
- Photoperiod: 12 hrs dark /12 hrs light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
Test material was applied to an area of shorn skin (approximately 10% of the total body surface). A piece of surgical gauze was placed over the treatment area and semi-occ;luded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
Cotton wool moistened with distilled water was used to remove any residual test material

TEST MATERIAL
The test material was applied at a dose level of 2000 mg/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Bodyweight was recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes, this consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths
Clinical signs:
other: There were no signs of systemic toxicity
Gross pathology:
No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material was > 2000 mg/kg bw. The test material is therefore not classified for acute dermal toxicity in accordance with Regulation (EC) No 1272/2008

Categories Display