Registration Dossier
Registration Dossier
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EC number: 201-089-0 | CAS number: 78-16-0
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:
- other: Basic data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.40
- Deviations:
- yes
- Remarks:
- limited documentation
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate
- EC Number:
- 201-089-0
- EC Name:
- 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate
- Cas Number:
- 78-16-0
- Molecular formula:
- C27H50O6
- IUPAC Name:
- 2,2-bis[(heptanoyloxy)methyl]butyl heptanoate
- Details on test material:
- - Physical state: yellow liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin of the trunk
- Type of wrap if used: the area was covered with gauze and wrapped with impervious material (not further specified).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed (not further decribed)
- Time after start of exposure: 24 h - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 (including 5 animals treated on intact and 5 animals treated on abraded skin; no details on the gender available).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily and individual body weights were determined on Day 0 and Day 14 of the study period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, skin irritation (24 h after application of the test substance)
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Slight to moderate diarrhea was observed in 5/10 animals on Days 8 to 14. Slight yellow discharge around the nose of one animal was observed on Days 6, 9 and 10 and worsened on Days 11 through 14. On Day 1, all 5 animals with intact skin and 4/5 animals
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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