Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

- only one sex, purity of test substance not specified, no recording of necropsy findings

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

EC Number:

295-714-4

EC Name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

Cas Number:

92128-22-8

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction products of tall-oil fatty acids and (3-aminopropyl)dimethylamine

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann (Borchen, Germany)
- Age at study initiation: about 9 weeks
- Weight at study initiation: 185 g (mean body weights)
- Fasting period before study: 16 hours
- Housing: 5 animals per group in Macrolon type III cages on dust-free wood granules
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5.0 ml/kg (4600 mg/kg)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of application as well as twice daily during observation period (clinical signs, mortality); surviving animals were weighed individually at application, after one week and at the end of the 14-day observation period.
- Necropsy of survivors performed: no

Statistics:

not specified

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: corresponds to > 4600 mg/kg bw

Mortality:

All 10 animals survived the treatment.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

no data

Other findings:

none

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test substance was low with an LD50 value > 4600 mg/kg bw (5 ml/kg bw) for male rats (similar to OECD TG 401). Single administration of 4600 mg/kg bw was tolerated without mortality and without signs of intoxication by all animals. Body weight development was not affected.