Tall oil, compd. with triethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 August 2005 to 7 September 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Justification for type of information:

Refer to RAAF document in section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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

EC Number:

232-304-6

EC Name:

Tall oil

Cas Number:

8002-26-5

Molecular formula:

Variable

IUPAC Name:

Tall Oil

Constituent 2

Reference substance name:

Crude Tall Oil

IUPAC Name:

Crude Tall Oil

Test material form:

liquid: viscous

Details on test material:

- Appearance: dark, high viscous liquid
- Storage Conditions: room temperature <25 °C in the dark, may be used under light
- Stability under storage conditions: stable

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: CrI:CD(SD)IGS BR
- Age at study initiation: Approximately 8 weeks at the time of administration.
- Weight at study initiation: 174 to 194 g
- Fasting period before study: Yes. The feed was withdrawn the evening before the administration of the test material and was offered again about three hours post administration.
- Housing: Single caging (39 x 23 cm bottom area, 18 cm high) with wire mesh lids.
- Diet (e.g. ad libitum): feed gamma irradiated with 25 kGy ⁶⁰Co, ad libitum.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.0 °C
- Humidity (%): Average of 70.6 %
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.

IN-LIFE DATES: From: 17 August 2005 To: 7 September 2005

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): The individual dose volumes were calculated using the bodyweights determined on the day of the administration.
- Justification for choice of vehicle: The test material was not soluble in water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test material was available, a starting dose of 300 mg/kg bodyweight was chosen. The solutions were freshly prepared before dosing and were administered within 20 minutes.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3 female animals per step (6 animals in total per dose level)

Control animals:

no

Details on study design:

The test material was administered sequentially to groups of 3 animals per step, using a starting dose of 300 mg/kg. After the initial group of rats had been dosed, a second group of animals received the test material at a dose level of 300 mg/kg.
In the absence of any toxicological effects, the test material was administered to a third group of animals at a dose level of 2000 mg/kg. A fourth and final group of animals then received the test material at the 2000 mg/kg dose level.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed within the periods 0 to 0.5, 0.5 to 1, 1 to 2, 2 to 4 and 4 to 6 hours after administration of the test material and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Bodyweights were determined before administration, 7 days post administration and 14 days post administration. Body weight gain was calculated for each week of the study, i.e. between 0 and 7 days and between 7 and 14 days following dosing.
- Necropsy of survivors performed: yes. The animals were killed by inhalation of 80 % CO₂ + 20 % air and subjected to a necropsy including a gross pathological examination.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

No signs of systemic toxicity were observed.

Body weight:

All animals showed the expected gains in bodyweight over the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the acute oral LD50 was >2000 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.

Executive summary:

The acute oral toxicity potential of the test material in female Sprague-Dawley strain rats was assessed in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris under GLP conditions.

The test material was administered by gavage as a solution in corn oil; the dosing was performed sequentially to groups of 3 animals per step using a starting dose of 300 mg per kg body weight and 2000 mg per kg body weight as the second dose. The animals were observed for 14 days.

There was no mortality and no clinical signs were observed. All animals showed the expected gains in bodyweight throughout the observation period.

Under the conditions of this study, the acute oral LD50 was >2000 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.