Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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:
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.
Body weight:
The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
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.