Tall oil, reaction products with diethylenetriamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 to 28 April 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tall oil, reaction products with diethylenetriamine

EC Number:

268-776-5

EC Name:

Tall oil, reaction products with diethylenetriamine

Cas Number:

68140-14-7

Molecular formula:

UVCB substance - not applicable

IUPAC Name:

Tall Oil, reaction products with diethylenetriamine

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: the test material (tall oil reaction products with diethylenetriamine) was provided by Baker Hughes Ltd., no batch number was available
- Expiration date of the lot/batch: 31 January 2016
- Purity test date: not supplied; purity >95%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: assumed stable for the study duration
- Solubility and stability of the test substance in the solvent/vehicle: arachis oil BP was used because the test item was not soluble in distilled water

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain/sex: Wistar (RccHan:WIST), female
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 162 - 186 g (the body weight variation did not exceed ±20% of the body weight of the initially dosed animal).
- Fasting period before study: overnight immediately before dosing
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 01 April 2015 To: 28 April 2015

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

for 300 mg/kg bw dose level only

Details on oral exposure:

For the purpose of the 2000 mg/kg bw dose level the test item was used as supplied. The specific gravity was determined to be 0.950 and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 300 mg/kg dose level the test item was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
The dose volume for the 300 mg/kg bw dose was 10 mL/kg bw with a concentration of 30 mg/mL. The dose volume for the 2000 mg/kg bw was 2.11 mL/kg bw. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing.

The test item was formulated within 2 hours of being applied to the test system. It was assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 1 female
2000 mg/kg bw: 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes; external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Statistics:

Not required.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occured.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No other findings reported.

Any other information on results incl. tables

No further information available.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 was estimated to be >2000 mg/kg bw in female rats and classification according to CLP is not required.

Executive summary:

The acute oral toxicity of 'tall oil reaction products with diethylenetriamine' was investigated in female Wistar rats, according to OECD 420. Following a sighting test in single rats at dose levels of 300 mg/kg bw and 2000 mg/kg bw, a further group of four females was given a single oral dose of the test item at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored for 14 days. All animals were subjected to gross necropsy at study termination.

No mortalities occurred and there were no clinical signs of toxicity. All animals showed expected body weight gains during the observation period. No abnormalities were noted at necropsy. Therefore, under the conditions of the study, the LD50 was estimated to be greater than 2000 mg/kg bw and classification according to CLP is not required.