Registration Dossier
Registration Dossier
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EC number: 815-182-4 | CAS number: 12058-75-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 November 2011 - 23 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Disodium hexatitanate
- EC Number:
- 815-182-4
- Cas Number:
- 12058-75-2
- Molecular formula:
- Na2Ti6O13
- IUPAC Name:
- Disodium hexatitanate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Otsuka Chemical Co Ltd, batch IC96
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 373 to 401 g for males, and 242 to 255 for females
- Fasting period before study:
- Housing: individually from Day -1
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23C
- Humidity (%): 40 to 70%
- Air changes (per hr): periodic checks
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10
- Type of wrap if used: The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30 - 40°C)
- Time after start of exposure: 24 hours
TEST MATERIAL
- Concentration (if solution): 2000 mg/kg bodyweight
VEHICLE
- Amount(s) applied (volume or weight with unit): 2.0 mL/kg bodyweight
- Concentration (if solution): 1% - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bodyweight
- 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: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 morning only).
- Frequency of weighing: Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths and no clinical signs were observed for any animal.
- Clinical signs:
- other: Very slight erythema was seen in one female (Animal No. F7) from Day 4 resolving by Day 15. No dermal reactions were seen in the remaining animals throughout the study
- Gross pathology:
- Macroscopic examination at study termination on Day 15 revealed pallor of the kidneys in four males (Nos. F1 – F4) and three females (Nos. F6 – F8). No abnormalities were revealed in any other animal at the macroscopic examination at this time.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute median lethal dermal dose (LD50) to rats of Terracess DSR was demonstrated to be greater than 2000 mg/kg bodyweight.
Terracess DSR is included in Category 5 or unclassified according to the Globally Harmonised System
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