Registration Dossier
Registration Dossier
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EC number: 806-731-9 | CAS number: 1428353-74-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class 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:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 200 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
All six animals in the 2000 mg/kg group survived to the scheduled necropsy (study
day 14).
Clinical observations were noted on study day 0 for 4 females at 2000 mg/kg and
consisted of soft feces, diarrhea, wet or dried yellow material on various body surfaces
and/or wet brown material on the anogenital area. In addition, dried yellow material on
the ventral trunk was observed for one of these females on study day 1.
Body weights were unaffected. There were no test substance-related macroscopic
findings.
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 as a single oral dose in female albino rats.
- Executive summary:
The acute oral toxicity was evaluated via oral gavage at a limit dose of 2000 mg/kg in female rats. All animals survived to scheduled necropsy. The LD50 is > 2000 mg/kg
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