Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-610-1 | CAS number: 68131-13-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 31 – June 22, 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: OPPTS 870.1000 “Acute toxicity testing background”
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class 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:
- Name: MK195KSF
Physical State at RT: hazy solid
Colour: orange/brown
Volatile: no
Density: 0.83
pH: 9.07
Active Components (%): 100
Storage: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The vehicle was chosen due to its non-toxic characteristics.
- Doses:
- The test item was administered at a dose volume of 5mL/kg body weight.
The starting dose was selected to be 2000mg/kg body weight. - No. of animals per sex per dose:
- 3 per step (step 1 and step 2)
- Control animals:
- yes
- Details on study design:
- All animals were observed for 14days after dosing for general clinical signs, morbidity and mortality.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Piloerection
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the eutanasia injection, no special gross pathologica changes were recorded for any animal.
Any other information on results incl. tables
Under the conditions of the present study, single oral application of the test item MK195KSF to rats at a dose of 2000mg/kg body weight was associated with slight signs of toxicity, but no mortality.
The median lethal dose of test item after single oral administration to female rats, observed over a period of 14days is:
LD50 cut off (rat): unclassified.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of test item after single oral administration to female rats, observed over a period of 14days is:
LD50 cut off (rat): unclassified.
In conformity with the criteria given in Annex Vi to Commission Directive 2001/59/EC, in according to Annex I of Regulation (EC) 1272/2008 and in according to OECD-GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
