Fatty acids, tall-oil, Bu esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

2002-01-15 to 2002-02-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

analytical purity of test substance not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Fatty acids, C16-18 and C18 unsatd. branched and linear, butyl esters
- Physical state: amber colored liquid
- Analytical purity: no data
- Storage condition of test material: RT in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: approx 8 weeks
- Weight at study initiation: minimum 200 g
- Fasting period before study: over night until 3 h after dosing
- Housing: groups of three separated by sex
- Diet (e.g. ad libitum): ad libitum (Certified rat and mouse diet)
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.25 mL/kg bw

DOSAGE PREPARATION (if unusual): The volume administered was calculated for each animal according to the fasted bodyweight and the specivic gravity of the test compound

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times on the day of dosing and once a day subsequently until day 14 on the day
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

No clinical signs of toxicity were observed up to the end of the observation period.

Body weight:

No effect on body weight was noted.

Gross pathology:

Gross pathology revealed no substance-related findings.

Any other information on results incl. tables

When administered orally as a single dose of 2000 mg/kg bw to rats the test substance caused no mortalities, abnormal clinical effects or changes in body weight gain. The test substance has not to be classified according to DSD and CLP.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified