Tall oil, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.07.05 to 03.11.05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:

8002-26-4

IUPAC Name:

Crude Tall Oil

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)IGS BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 8 weeks
- Weight at study initiation: 174-194 g
- Fasting period before study: Feed was withdrawn the evening before administration until three hours after administration.
- Housing: Individually caged in Makrolon cages type III
- Diet (e.g. ad libitum): Ad libitum (except during fasting)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (average)
- Humidity (%): 70.6 (average)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 17-08-05 To: 07-09-05

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): Total of 10 ml/kg bw used
- Justification for choice of vehicle: The test substance was not soluble in water, and corn oil is a common vehicle for acute oral toxicity testing.
- Lot/batch no. (if required): No data
- Purity: No data


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test substance was available, a starting dose of 300 mg/kg bw was chosen.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

Three

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed within the periods 0-0.5, 0.5-1, 1-2, 2-4 and 4-6 hours after administration of the test substance and then at least once per day up to two weeks. Body weights were determined before administration and 7 and 14 days after administration.
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No animals died

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

other: There were no clinical signs of toxicity.

Gross pathology:

There were no findings during the gross pathological examination.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a good quality acute oral toxicity study (reliability score 1) conducted to OECD test guideline 423, and GLP, the LD50 for Crude Tall Oil was greater than 2000 mg/kg bw in Crl:CD(SD)IGS BR rats.

Executive summary:

Crude Tall Oil was administered once as a solution in corn oil (10 ml/kg bw), given orally via gavage to female Crl:CD(SD)IGS BR rats. The dosing was performed sequentially to groups of three animals per step using a starting dose of 300 mg/kg bw and 2000 mg/kg bw as the second dose. The animals were then observed for 14 days. Clinical observations were noted at least once per day, body weights were recorded before administration, and on days 7 and 14. At the end of the observation period all animals were sacrificed and necropsied. There were no clinical signs of toxicity, no deaths and all animals gained weight normally. The oral LD₅₀ was therefore greater than 2000 mg/kg bw.