N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

Repeated dose toxicity: dermal

Administrative data

Endpoint:

sub-chronic toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 82-3 (Subchronic Dermal Toxicity 90 Days)

Deviations:

yes

Remarks:

see, principles of method if other than guideline

Principles of method if other than guideline:

The high dose level was lowered because of the severe irritation (eschar formation) of the application skin site as it could potentially decrease dermal absorption of the test substance. This change was not considered to effect the integrity of the study.

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

EC Number:

219-145-8

EC Name:

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

Cas Number:

2372-82-9

Molecular formula:

C18H41N3

IUPAC Name:

bis(3-aminopropyl)(dodecyl)amine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

6 hours/day, 90 days

Frequency of treatment:

5 days a week

Doses / concentrations

Remarks:

Doses / Concentrations:
0.25%, 0.5% and 1.0% a.i. (1.0% reduced to 0.75% after approximately one week of dosing), corresponding to 5, 10 and 20 (15) mg a.i./kg bw/day
Basis:
nominal per unit body weight

No. of animals per sex per dose:

Cohort I : 46 rats/sex,
5 dose groups of 8 rats/sex/group
Cohort II: 69 rats/sex
4 groups of 15 rats/sex/group

Control animals:

yes

Results and discussion

Effect levels

1

Key result

Dose descriptor:

NOEL

Remarks:

(systemic effects)

Effect level:

15 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: no effects at any tested dose

2

Key result

Dose descriptor:

LOAEL

Remarks:

(local effects)

Effect level:

5 mg/kg bw/day (actual dose received)

Based on:

act. ingr.

Sex:

male/female

Basis for effect level:

dermal irritation

Target system / organ toxicity

Key result

Critical effects observed:

no

Any other information on results incl. tables

NOEL was established at 15 mg a.i./kg bw. No evidence of an immunotoxicity or systemic toxicity was seen following dermal application of the test substance at dose levels up to 15 mg/kg bw for 6-7 (immuntoxicity evaluation) or 13-14 (systemic toxicity) weeks. All effects seen in the study were attributed to local irritation caused by dermal application of the test substance. With respect to local skin effects, no NOAEL was established.

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the 90 d NOEL of the test substance was established at 15 mg a.i./kg bw in rats.

Executive summary:

A study was conducted to determine dermal repeated dose toxicity of the test substance to Sprague Dawley rats for a minimum of 90 d according to EPA OPP Guideline 82-3, in compliance with GLP. Animals were exposed to the test substance at concentrations of 5, 10 and 20 (15) mg a.i./kg bw/day for duration of 6 h/day. There were no evidence of immunotoxicity or systemic toxicity following dermal application of the test substance at dose levels up to 15 mg a.i./kg bw/day for 6-7 (immunotoxicity evaluation) or 13-14 (systemic toxicity) weeks. All effects seen in the study were attributed to local irritation. With respect to local skin effects, no NOAEL was established. Under the study conditions, the 90 d NOEL of the test substance was established at 15 mg a.i./kg bw in rats (Johnson, 2000).