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Registration Dossier
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EC number: 274-324-8 | CAS number: 70131-50-9
Acute Toxicity: dermal
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:
- 2 010
- 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
- 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
Constituent 1
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
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