Registration Dossier
Registration Dossier
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EC number: 283-563-7 | CAS number: 84682-03-1
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: Limited study details are provided, preGLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Neodecanoic acid
- EC Number:
- 248-093-9
- EC Name:
- Neodecanoic acid
- Cas Number:
- 26896-20-8
- Molecular formula:
- C10H20O2
- IUPAC Name:
- neodecanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Versatic 10
- Physical state: liquid
- Analytical purity: assumed 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory
- Age at study initiation: 12 weeks
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar skin
- % coverage:
- Type of wrap if used: bandaged into contact with the skin using an impermeable dressing of aluminum foil and waterproof plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): dilute detergent solution
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration (if solution): assumed 100% - Duration of exposure:
- 24 hours
- Doses:
- 4 ml/kg (3640 mg/kg)
- No. of animals per sex per dose:
- 2 rats per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 9 days
- Frequency of observations and weighing: daily - Statistics:
- LD50 was calculated
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 640 mg/kg bw
- Remarks on result:
- other: No animals died
- Mortality:
- No animals died
- Clinical signs:
- other: No adverse effects noted
- Gross pathology:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 for neodecanoic acid is greater than 3640 mg/kg.
- Executive summary:
In this study male and female rats were exposed to 4 ml/kg (3640 mg/kg) neodecanoic acid via an occluded dermal patch for 24 hours. After 24 hours, the patch was removed and clinical observations were made once daily for 9 days. There were no deaths observed in this study and there were no signs of a toxicity response. It is concluded that the LD50 is greater than 3640 mg/kg.
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