Registration Dossier
Registration Dossier
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EC number: 806-731-9 | CAS number: 1428353-74-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 9, 2015 to June 11, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol
- EC Number:
- 806-731-9
- Cas Number:
- 1428353-74-5
- Molecular formula:
- Substance is a UVCB.
- IUPAC Name:
- Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol
- Test material form:
- other: liquid
- Details on test material:
- Identification: TS13001Physical state/Appearance:amber colored liquidExpiry Date: 30 January 2015Storage Conditions:room temperature in the darkIntended use/Application: Lubricating oil additive
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- 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 male and 5 female
- Control animals:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
There were no deaths, clinical observations, or remarkable body weight changes. There
were no gross necropsy findings for any examined tissues.
All animals were noted with very slight (grade 1) to slight (grade 2) erythema.
Desquamation, encrustation, scabbing within dose site, and pinpoint scabbing were
observed for 7, 3, 3, and 2 animals, respectively. Exfoliation was limited to 1 animal.
Very slight erythema, desquamation, and pinpoint scabbing were present for the same
animal at study termination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the estimated LD50 was greater than 2000 mg/kg when administered once dermally for 24 hours to the clipped, unabraded skin of male and female albino rats.
- Executive summary:
The dermal LD50 was > 2000 mg/kg in a guideline GLP study.
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