Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

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