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Toxicological information

Acute Toxicity: oral

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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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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): 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 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- Fasting period before study: Feed was withdrawn the evening before administration until three hours after administration.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
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No animals died
Mortality:
All animals survived until the scheduled termination of the study.
Clinical signs:
There were no clinical signs of toxicity.
Body weight:
All animals gained weight as expected.
Gross pathology:
There were no findings during the gross pathological examination.
Other findings:
No other findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information 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 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.