Fatty acids, tall-oil, compds. with triethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 September 1983 to 13 October 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Read-across is considered to be suitable based on the structural similarities between the read across substance and the test substance

Cross-reference

Reason / purpose for cross-reference:

other: read-across target

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil

EC Number:

263-107-3

EC Name:

Fatty acids, tall-oil

Cas Number:

61790-12-3

IUPAC Name:

fatty acids, tall-oil

Test material form:

liquid

Details on test material:

- Appearance: yellow liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 180 to 280 g (after fasting)
- Fasting period before study: 18 hours
- Housing: Rats housed in groups, according to sex, or individually in stainless steel 0.5 inch, wire mesh cages. Waste material was removed daily. Cages and feeders were sanitised every two weeks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light, 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 g/kg
- The test material was dosed as supplied
- Rationale for the selection of the starting dose: based on the request of the sponsor

Doses:

10 g/kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- The animals were observed immediately, and at 1 and 4 hours after dosing and daily thereafter for pharmacotoxic, CNS effects and mortality.
- Body weights were recorded initially and at the time of death.
- Necropsy of survivors performed: yes, the surviving animals were sacrificed on Day 14 by CO2 inhalation and a gross necropsy was performed.

Statistics:

No statistical analysis was perfomed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Clinical signs:

Signs observed included piloerection and abnormal stance.

Body weight:

Body weights increased during the study. Initial bodyweights for males were 221.2 g and for females were 207 g and the final body weights for males were 343.4 g and for females were 260.6 g.

Gross pathology:

No test material related lesions were observed in any animal upon terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg.

Executive summary:

The acute oral toxicity of the test material to rats was investigated under GLP conditions.

The test material was administered at 10 g/kg by gavage to one group of ten rats (5 per sex) which were fasted for 18 hours prior to dosing. The rats were observed immediately, and at 1 and 4 hours after dosing and daily thereafter for clinical signs and mortality. Body weights were recorded initially and at the time of death. The surviving rats were sacrificed 14 days after dosing by CO2 inhalation and subjected to a gross necropsy.

No mortality was observed at a dose of 10 g/kg. There were no significant clinical signs seen at this dose level. All animals gained weight and no visible lesions were observed in the surviving animals upon terminal necropsy.

Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg.

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