Amines, N-(C18-unsatd. alkyl)trimethylenedi-, ethoxylated

Repeated dose toxicity: dermal

Administrative data

Endpoint:

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:

1977

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Illegible copy of old report submitted for TSCA 8(e)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-tallow alkyltrimethylenedi-, ethoxylated

EC Number:

500-149-6

EC Name:

Amines, N-tallow alkyltrimethylenedi-, ethoxylated

Cas Number:

61790-85-0

Molecular formula:

C19-21 H42-46 N2 (C2H4O)(n+m+k)

IUPAC Name:

tallow alkyldiamine ethoxylate

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

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.