Registration Dossier
Registration Dossier
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EC number: 248-469-2 | CAS number: 27458-92-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Range-Finding Toxicity Data: List VI
- Author:
- Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C. and Striegel, J.A.
- Year:
- 1 962
- Bibliographic source:
- Am. Ind. Hyg. Assoc. J.: 23(4), 95-107
Materials and methods
- Principles of method if other than guideline:
- The LD50 was determined by a method closely akin to the one-day cuff method of Draize et al. (1944) using groups of 4 male albino New Zealand rabbits. The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 607-896-8
- Details on test material:
- - Name of test material (as cited in study report): Tridecanol (mixed primary isomers)
- Analytical purity: not stated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Duration of exposure:
- 24 h
- Doses:
- no data
- No. of animals per sex per dose:
- 4 male animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- LD50 value and its confidence interval was estimated by the method of Thompson (1947) using the tables of Weil (1952).
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 7.07 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: (confidence intervals: 2.33 - 21.4 ml/kg bw; = ca. 5960 mg/kg bw, confidence interval: 1964 - 18040 mg/kg bw, calculated by the density of 843 g/l)
- Mortality:
- no data
- Clinical signs:
- other: no data
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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