Registration Dossier
Registration Dossier
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EC number: 205-448-2 | CAS number: 141-02-6
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:
- other: No OECD guideline available at the study performance date.
Data source
Reference
- Reference Type:
- publication
- Title:
- Range-Finding Toxicity Data: List V
- Author:
- Smyth HF
- Year:
- 1 954
- Bibliographic source:
- Archives of Industrial Hygiene and Occupational Medicine vol 10, pp 61-68
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- method akin to the one-day cuff method of Draize 1944 (Methods of study for irritation and toxicity of substances applied topically to the skin and mucous membranes, Journal Pharmacol. Exp. Therap. 82:377).
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Bis(2-ethylhexyl) fumarate
- EC Number:
- 205-448-2
- EC Name:
- Bis(2-ethylhexyl) fumarate
- Cas Number:
- 141-02-6
- Molecular formula:
- C20H36O4
- IUPAC Name:
- bis(2-ethylhexyl) but-2-enedioate
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- body weight: 2.5–3.5 kg
Administration / exposure
- Details on dermal exposure:
- - fur removed from the entire trunk by clipping
- dose retained beneath an impervious plastic film
- immobilisation of the animals during exposure
- observation for 14 days after the end of exposure - Duration of exposure:
- 24 hours
- Doses:
- no data
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- no data
- Statistics:
- LD50: method of Thompson and Weil
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Mortality:
- no data
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50, dermal, rabbit was > 20mL per kg body weight when applied for 24 hours to the intact skin of rabbits.
- Executive summary:
The test substance was applied to the intact skin of 4 male rabbits per group for 24 hours. The animals were observed for mortalities for further 14 days. The LD50, calculated according to the method of Thompson and Weil, was > 20 mL per kg body weight which is equal to 18840 mg/kg bw.
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