Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5.9.2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C12-18 and C18-unsatd., reaction products with N,N-dimethyl-1,3-propanediamine and triethanolamine
Cas Number:
91845-03-3
Molecular formula:
Unknown
IUPAC Name:
Fatty acids, C12-18 and C18-unsatd., reaction products with N,N-dimethyl-1,3-propanediamine and triethanolamine
Test material form:
solid: bulk
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and package No.of test material: manufactured in Sevelen, lot #19953859
- Expiration date of the lot/batch: 020.01.2020

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Elix, Millipore S.A.S., Molsheim, France
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - <= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Expected results
Mortality:
None

Applicant's summary and conclusion

Interpretation of results:
other:
Conclusions:
We expect LD50 to be >2000 mg/kg bw.
Executive summary:

We expect LD50 to be >2000 mg/kg bw. This estimation is based on the facts that the LD50 of CAS 7551 -02 -7 which is also part of the this UVCB, showed LD50 >2000 mg/kg bw. See REACh Dossier: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/14377/7/3/1