Registration Dossier
Registration Dossier
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EC number: 470-870-8 | CAS number: 690271-93-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 July 2004 to 5 January 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP in accordance with an internationally recognised test guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: Ministry of Agriculture, Forestry, and Fisheries (MAFF) (1985). 59 NohSan Number 4200, Acute Dermal Toxicity. Testing Guidelines for Toxicity Studies
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Terracess TF
- IUPAC Name:
- Terracess TF
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Terracess TF-L
- Appearance: white powder
- Purity: 99.6%
- Lot/batch No.: 4B83
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)IGS BR
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Substance as such
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 5 cm x 7.4 cm
- Type of wrap if used: 2-ply gauze patch. then stretch gauze bandage and self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): equivalent to 5000 mg/kg bw
- For solids, paste formed: yes (with 0.7 ml of deionised water - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg
- 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: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin response
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: None
- Gross pathology:
- No gross lesions were present in the rats at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the skin absorption LD50 for Terracess TF-L was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.
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