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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

sub-chronic toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Illegible copy of old report submitted for TSCA 8(e)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline available
GLP compliance:
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, N-tallow alkyltrimethylenedi-, ethoxylated
EC Number:
EC Name:
Amines, N-tallow alkyltrimethylenedi-, ethoxylated
Cas Number:
Molecular formula:
C19-21 H42-46 N2 (C2H4O)(n+m+k)
tallow alkyldiamine ethoxylate

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Adequate assessment of the available data is not possible, and therefore this study is disregarded.
Executive summary:

Information is from TSCA 8(e) submission. The cover letter includes the following information:

"Submission is being made pursuant to the TSCA Section 8(e) Compliance Audit Program and the terms of CAP Agreement #8ECAP-0003."

"The material identified in the attached report as E 7017 is Amines, N-tallow alkyltrimethylenedi-, ethoxylated, CAS# 61790-85-0. "

"This study summarizes the effect of percutaneous treatment of rabbits with 0, 0.77 or 7.7 mg/kg/day for 91 days. Treatment with the test material resulted in slight to moderate skin irritation in both dose groups. Two of six rabbits in the high dose group had aggregations of foamy macrophages scattered throughout the mesenteric lymph nodes. No other remarkable findings were noted. The finding of "foamy macrophages" refers to phospholipidosis, a common effect observed following administration of cationic amphiphilic materials, including marketed pharmaceuticals. This effect has not been associated with immunotoxicity, and host resistance assays conducted on quaternary ammonium compounds have failed to demonstrate effects on immune function, even at doses approaching overt toxicity. "

The results for 7.72 mg report slight to moderate dermal irritation, but also foamy macrophages in mesenteric lymph nodes in 2/6 animals. No other effects. As these effects are local reactions following the route of absorption, it is most likely that this is most likely a consequence following oral uptake from grooming.

Adequate assessment of the available data is not possible, and therefore this study is disregarded.