Fatty acids, C18, unsatd., dimers, reaction products with N,N-dimethyl-1,3-propanediamine and 1,3-propanediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

of 1981

Deviations:

yes

Remarks:

Due to physicochemical properties of the test material and to achieve the high target doses dose volumes could not be kept constant but increased with increasing dose up to the double volume of that recommended by OECD401 for non-aqueous dose formulations

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA, 1959

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Wistar rats, strain: Winkelmann, Paderborn (SPF-Quality) with appropriate range of bodyweight at study start.
- Weight at study initiation (day of dosing): Males: minimum 200 g, maximum 216 g,
Females: minimum 195 g, maximum 206 g.
- Housing: Group housing with up to 5 animals by sex in cages.
- Fasting period: From 16 hours before test start
- Diet (except for fasting period): Commercially available standard laboratory animal diet:
"Rat/Mouse Maintenance" from Altromin, Lage, Germany
- Water was provided ad libitum

ENVIRONMENTAL CONDITIONS

The animal room was maintained at:
- Temperature (°C): 22 ± 1°C
- Relative Humidity (%): 45 to 55%
- Photoperiod (artificial lighting): 12 h/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Emulsion in mixture of CMC (carboxymethyl cellulose) and Tween 20 containing 50% of the test substance

Details on oral exposure:

- Dose formulation: 50% of the test substance in vehicle, i.e. emulsion at the maximum practical concentration
- Dose volume: The administered volume of test material formulation increased with increasing dose thus achieving quite high target doses.
Individual dose volume was calculated based on individual bodyweight
- For different doses and dose volumes, see Table 1 in "Any other information on materials and methods incl. tables"
- Rationale for doses selected: Based on a pre-test, which was not detailed in the study report.

Doses:

see Table 1 in "Any other information on materials and methods incl. tables"

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
It has not been clearly specified in the report at what time points clinical signs and mortality were recorded, but the following records have been
reported:
Clinidal signs: At least shortly after dosing (Day 0) and at 7 and 14 days post dosing.
Mortality: At least at 24 hours, 7 days and 14 days post dosing.
Weighing of each animal: All animals on Day 0 for calculation of individual dose volume and on Day 14 (end of observation period).
- Necropsy: All animals were necropsied at termination of the study.

Statistics:

LD50 was estimated for 24 hours and 14 days post dosing. Determination of a slope function was inappropriate as there were no deaths in both dose groups.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths at 5000 or 10000 mg/kg.

Mortality:

There were no deaths during the 14-day observation period post dosing:
Single Dose at: Mortality
5000 mg/kg bw 0/5 (m); 0/5 (f)
10000 mg/kg bw 0/5 (m); 0/5 (f)

Clinical signs:

Shortly after dosing and 7 and 14 days afterwards clinical signs attributable to the treatment with the test material were not evident.

Body weight:

There were no adverse effects on body weight.

Gross pathology:

Macroscopic pathology findings attributable to the treatment with the test material were not evident.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to EU regulation