Registration Dossier

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:
2010
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 (Acute Toxicity (Oral))
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

Constituent 1
Chemical structure
Reference substance name:
Fatty acids C10-20, reaction product with diethylenetriamine
EC Number:
940-308-0
IUPAC Name:
Fatty acids C10-20, reaction product with diethylenetriamine
Test material form:
liquid: viscous
Details on test material:
Test name of the substance: Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Old name of the test material: MK195KSF
Physical State at RT: hazy solid
Colour: orange/brown
Volatile: no
Active Components (%): 100
Storage: at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
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

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Mortality: No mortality

Clinical signs: Piloerection

Body weight: None of the animals showed weight loss during the observation period

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.

Under the conditions of the present study, single oral application of the test item Fatty acids, C10 -20 neo, reaction product with diethylenetriamine 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 (rat) > 2000 mg/bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose of test item after single oral administration to female rats, observed over a period of 14days is: LD50 (rat) > 2000 mg/bw.
The test item doesn't require hazard classification.