Registration Dossier
Registration Dossier
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EC number: 262-992-3 | CAS number: 61788-64-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: Read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read Across from a GLP well conducted study on the supporting structural related substance
- Justification for type of information:
- The justification for the use of the similar substance is detailed in the Read Across document attached in section 13
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:
- Rape oil, bisulfited, sodium salt
- EC Number:
- 281-975-1
- EC Name:
- Rape oil, bisulfited, sodium salt
- Cas Number:
- 84082-27-9
- IUPAC Name:
- Rape oil, bisulfited, sodium salt
- Details on test material:
- - Name of test material (as cited in study report): FLL sample 4
- Physical state: viscous liquid
- Lot/batch No.: 240210
- Expiration date of the lot/batch: not reported
- Storage condition of test material: room temperature in the dark
- Other: yellow/brown color
- All other template details: Not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HsdRccHan(TM)WIST
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/Kg
- No. of animals per sex per dose:
- 5 males and 5 females
- 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:
- males: 0/5
females: 0/5
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Accordinf to CLP Criteria used for interpretation of results: EU
- Conclusions:
- The dermal median lethal dose was > 2000 mg/kg for acute (24-hour) exposure for rat. This does not classify the substance under the CLP regulation.
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