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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See 2018_Read-across-Justification_V1 in attached justification

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethyloctadecylamine N-oxide
EC Number:
219-919-5
EC Name:
N,N-dimethyloctadecylamine N-oxide
Cas Number:
2571-88-2
Molecular formula:
C20H43NO
IUPAC Name:
N,N-dimethyloctadecanamine oxide

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 706 mg/kg bw
Based on:
other: Based on Amine Oxides

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
As indicated in the read-across justification, data from Amine oxide can be used for read-across to N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) acute oral toxicity.
Concerning the read-across approach, the data on the other C18 Amine Oxide (Dihydroxyethyl oleamine oxide - CAS 93962-62-0) was used to determine the LD50 of N,N-Dimethyl-1-octadecanamine-N-oxide :
- The LD50 female rat is 1 706 mg/kgbw
- The LD50 male rat is 7 489 mg/kgbw
Executive summary:

As indicated in the read-across justification, data from Amine oxide can be used for read-across to N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) acute oral toxicity.

Concerning the read-across approach, the data on the other C18 Amine Oxide (Dihydroxyethyl oleamine oxide - CAS 93962-62-0) was used to determine the LD50 of N,N-Dimethyl-1-octadecanamine-N-oxide :

  • The LD50 female rat is 1 706 mg/kgbw
  •  The LD50 male rat is 7 489 mg/kgbw