Fatty acids, tall-oil, reaction products with diethylenetriamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant OECD guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with diethylenetriamine

EC Number:

263-160-2

EC Name:

Fatty acids, tall-oil, reaction products with diethylenetriamine

Cas Number:

61790-69-0

Molecular formula:

Monoamides: C22H43N3O / C22H45N3O Diamides: C40H73N3O2 / C40H75N3O2 / C40H77N3O2

IUPAC Name:

Amidation products of tall-oil fatty acids with diethylenetriamine

Details on test material:

- Name of test material (as cited in study report): INTERMEDIO UB 2
- Substance type: UVCB
- Physical state: solid, light yellow mass
- Lot/batch No.: 11 C 071

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- SPF-Wistarrats strain Winkelmann, Paderborn
- Mean weight males: 220 - 230 g
- Mean weight females: 190 - 210 g
- Fasting period before study: 16 hours
- Housing: 3 animals per sex per cage, randomly divided in single cages
- Diet: laboratory standard diet (Altromin, Lage), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22.5 ± 2.5 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The test substance was warmed at 60 °C and suspended in olive oil with help of ULTRATURRAX and some drops of Tween 80.
Administration by oral gavage, using a non-flexible stomach tube.

Doses:

Group 1: 2000 mg/kg/bw (10 p.c.)
Group 2: 4000 mg/kg/bw (20 p.c.)
Frequency: single dosage, on day 1

No. of animals per sex per dose:

3 animals per dose/sex

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 h, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic organ changes

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Mortality:

No mortalities occured.

Clinical signs:

other: No clinical signs of systemic toxicity were noted.

Gross pathology:

No clear pathologic findings did occur in final autopsy in any of big body cavities and no pathological changes macroscopically could be observed which were due to the test procedure or the test compound.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of INTERMEDIO UB 2 in Wistar rats was established to exceed 4000 mg/kg body weight.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), INTERMEDIO UB 2 does not have to be classified and has no obligatory labelling requirement for oral toxicity.