Registration Dossier
Registration Dossier
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EC number: 268-610-1 | CAS number: 68131-13-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 26- June 10, 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Naphthenic acids, reaction products with diethylenetriamine
- EC Number:
- 268-610-1
- EC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Cas Number:
- 68131-13-5
- Molecular formula:
- C16H21N3O2 (minimal)
- IUPAC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Details on test material:
- product name: MK195KSF
Sample description: orange/brown hazy solid
Volatile: no
Density: 0.83
pH: 9.07
Storage conditions: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of the total body surface
- Type of wrap if used: gauze-dressing and non-irritating tape fixed with additional dressing in a suitable manner. - Duration of exposure:
- The test item will be held in contact with the skin throughout a 24 hour period.
- Doses:
- The test item will be applied at single dose of 2000mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5 female and 5 male
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Slight piloerection, bloody nasal discharge, regurgitation were observed in one female only immediately after the removal of the dressing. Bbloody nasal discharge was observed in three males animals.
- Gross pathology:
- No specif gross pathological changes were recorded.
Any other information on results incl. tables
LD 50 cut-off
Dose (Unit) |
Number of Animals Investigated |
Number of Intercurrent Deaths |
LD50 |
2000 mg/kg bw |
5 females |
0 |
> 2000 mg/kg bw |
2000 mg/kg bw |
5 males |
0 |
> 2000 mg/kg bw |
Under the test conditions a single dermal application of the test item to rats at a dose of 2000mg/kg b.w. was associated with slight to moderete signs of irritation and signs of toxicity, but no mortality.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The dermal LD50 was determined to be > 2000 mg MK195KSF-Naphthenic acids, reaction products with diethylenetriamine/kg body weight.
The test item doesn't require classification.
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