Tall oil

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:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP,, using a closely-related test substance.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

17.07.05 to 03.11.05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP,, using a closely-related test substance.

Reason / purpose for cross-reference:

read-across source

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.

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

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, whose chemical composition is similar to that of Distilled Tall Oil, was greater than 2000 mg/kg bw in Crl:CD(SD)IGS BR rats. It can therefore be concluded that the acute oral LD50 for Distilled Tall Oil is also >2000 mg/kg.

Executive summary:

This data is being read across from the source study that tested Crude Tall Oil based on analogue read across.

 

Read-across from CTO to DTO is justified on the grounds that all the chemical constituents that are present in DTO are present in CTO i.e. fatty acids, resin acids, polymers and neutral compounds containing alcohols, hydrocarbons etc. The chemical constituent blocks of which they are comprised are compositionally very similar and are made up of constituents with common functional groups and properties. As a result the substances share very similar physicochemical properties both in terms of their bulk properties and the properties of the constituent blocks. CTO does contain some constituents that are not present in DTO and for this reason read-across from DTO to CTO is not considered appropriate. However for the purposes of read-across from CTO to DTO this is only likely to make the outcome conservative i.e. if anything the hazard of DTO is likely to be overestimated. A more detailed description of the technical justification for read-across is given in Section 1.4 of the CSR.

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.

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

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Crude Tall Oil
- Substance type: Complex mixture
- Physical state: Dark high viscous iquid
- Analytical purity: No data
- Composition of test material, percentage of components: Complex mixture
- Purity test date: No data
- Lot/batch No.: 2005-06-09, sample 4.
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature <25oC, in the dark, may be used under light.

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:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

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, whose chemical composition is similar to that of Distilled Tall Oil, was greater than 2000 mg/kg bw in Crl:CD(SD)IGS BR rats. It can therefore be concluded that the acute oral LD50 for Distilled Tall Oil is also >2000 mg/kg.

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.