Fatty acids C18 unsat, reaction products with Pentaethylenehexamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

15 July 2009 - 12 August 2009

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tall oil, reaction products with tetraethylenepentamine

EC Number:

271-417-5

EC Name:

Tall oil, reaction products with tetraethylenepentamine

Cas Number:

68555-22-6

IUPAC Name:

68555-22-6

Constituent 2

Reference substance name:

Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline)

IUPAC Name:

Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline)

Details on test material:

- Name of test material (as cited in study report): Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline)
- Substance type: Clear slightly viscous amber liquid
- Physical state: liquid
- Analytical purity: See Certificate of Analysis
- Lot/batch No.: S000925
- Expiration date of the lot/batch: 07 March 2017
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark under nitrogen

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:WI (Han)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

6 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:0, 2 and 4 hrs after dosing on Day 1 and daily thereafter. Weighing: weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

One female at 2000 mg/kg was found dead on Day 2. No mortality occurred among other animals at 2000 mg/kg, or among animals at 300 mg/kg.

Clinical signs:

other: Clinical signs observed during the study period were as follows: Dose level Clinical signs 300 mg/kg Lethargy, hunched posture, uncoordinated movements and/or piloerection on Day 1. 2000 mg/kg Hunched posture and/or piloerection between Days 1 and 4.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The oral LD50 value of Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline) in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight.

Executive summary:

Assessment of acute oral toxicity with Tall oil reaction products with tetraethylene-pentamine in the rat (Acute Toxic Class Method).

The study was carried out based on the guidelines described in:

- OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"

- Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method"

- EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"

- JMAFF guidelines (2000) including the most recent partial revisions.

Initially, Tall oil reaction products with tetraethylene-pentamine was administered by oral gavage to three female Wistar rats at 300 mg/kg body weight. In a stepwise procedure additional groups of females were dosed at 300 and 2000 mg/kg body weight. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15).

One female at 2000 mg/kg was found dead on Day 2. No mortality occurred among other animals at 2000 mg/kg, or among animals at 300 mg/kg.

Clinical signs observed during the study period were as follows:

Dose level Clinical signs

300 mg/kg Lethargy, hunched posture, uncoordinated movements and/or piloerection on Day 1.

2000 mg/kg Hunched posture and/or piloerection between Days 1 and 4.

The mean body weight gain shown by the surviving animals over the study period was considered to be normal.

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of Tall oil reaction products with tetraethylene-pentamine in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight.

This study on Tall oil, reaction products with tetraethylenepentamine is valid for the evaluation of AAI substances for which higher ethyleneamines were used such as Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).

All substances within the AAI group show the same reactive groups, show similar composition of amide, imidazoline, and some dimer structures of both, with the length of original EA amines used for production as biggest difference. Inherent reactivity and toxicity is not expected to differ much between these substances. Available data from repeated dose studies performed on various representative substances over the group of AAI indicates that toxicity decreases with increasing length of EA groups. For cross-reading in general, use can be made with data of same or lower EA-length where available, which if a difference would be expected at all, could be taken as worst case assumption.