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EC number: 603-330-9 | CAS number: 129332-29-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 November 2001- 21 November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
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))
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
- EC Number:
- 603-330-9
- Cas Number:
- 129332-29-2
- Molecular formula:
- C28H34FNO4
- IUPAC Name:
- tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 males and 5 females were used as test animals.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- polyethylene glycol
- Duration of exposure:
- 15 days
- Doses:
- Single dose on day 1 of 2000mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females were used as test animals.
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One male was found dead on day 1. No further mortality occured.
- Clinical signs:
- Hunched posture was noted among two makes and one femaleon days 2 and/or 3.
Maculate or general erythema was seen on the treated skin area of four females during the observation period.
No clinical signs were shown by the animal that died on day 1. The surviving animals had recovered from the symptoms between days 4 and 12. - Body weight:
- The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
- Gross pathology:
- No toxicologically significant abnormalities were found at macroscopic post mortem examinationof the animals. Pelvic dilation of the kidneys was noted in one male and one female. This finding is considered to be within the background pathology encountered for rats of this age and strain.
No macroscopic abnormalities were noted among the other animals, including the animal that died on day 1.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for dermal toxicity. LD50 > 2000mg/kg bw
- Executive summary:
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for dermal toxicity. LD50 > 2000mg/kg bw
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