Registration Dossier
Registration Dossier
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EC number: 296-473-8 | CAS number: 92704-41-1 The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 17 Dec - 31 Dec 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-guideline study tested, with the source substance Kaolin, clay. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Satintone 5HB
- PSL Code Number E61114-1R
- Physical state/appearance: white powder
- Analytical purity: no data
- Composition of test material, percentage of components: Kaolin clay - 100%
- Lot/batch No.: Lot No 10146
- Expiration date of the lot/batch: Not applicable
- Stability: stable
- Storage condition of test material: Room temperature
- Solubility: Suspendable in water
- pH: 5-6
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA
- Age at study initiation: young adult
- Weight at study initiation: males 202 - 221 g, females 165 - 180 g
- Fasting period before study: 19 hours
- Housing:stainless steel cages, mesh floor, litter paper, cages are conform to the size recommendations in the guide for the Care and Use of laboratory Animals DHEW (NIH) No. 86.23
- Diet (e.g. ad libitum): Purina Rodent Chow No. 5012
- Water (e.g. ad libitum): ad libitum filtered tap water (by an automatic water dispensing system)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 -73 °F
- Temperature (°C): 20 - 22.8 °C
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE: distilled water
- Concentration in vehicle: 36% w/w suspension
- Justification for choice of vehicle: preliminary solubility test (suspensions in excess of 36% were too viscous to be administered properly)
MAXIMUM DOSE VOLUME APPLIED: 2.4 mL
DOSAGE PREPARATION: calculated based on the initial bodyweights, taking into account the specific gravity and concentration of the test suspension - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- 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 signs of gross toxicity and behavioral changes at 1 and 3 hours post-dosing and at least once daily thereafter for 14 days.
Individual bodyweights were recorded prior to test substance administration and again on days 7 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy (tissues and organs of the thoracic and abdominal cavities)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived.
- Clinical signs:
- other: All animals appeared active and healthy after administration of 5000 mg/kg bw test substance during the 14 day observation period. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
- Gross pathology:
- Gross necropsy findings at terminal sacrifice were generally unremarkable. Apart from red lung discoloration consistent with euthanasia via CO2 inhalation, all tissues and organs appeared normal.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
