Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11.06.2018 - 10.09.2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine

EC Number:

295-171-3

EC Name:

Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine

Cas Number:

91845-01-1

Molecular formula:

C24H48NO4, C25H51N2O3

IUPAC Name:

2-(dimethylamino)ethyl hexadecanoate; 2-(dimethylamino)ethyl octadecanoate; N-[3-(dimethylamino)propyl]hexadecanamide; N-[3-(dimethylamino)propyl]octadecanamide

Test material form:

solid: bulk

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and package No.of test material: manufactured in Sevelen, lot #51716
- Expiration date of the lot/batch: 09.04.2019

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Target temperatures of 18 to 24°C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 21 to 22°C with an actual daily mean relative humidity of 32 to 65% (see deviations in Appendix 3). A 12-hour light/12-hour dark cycle was maintained. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Elix, Millipore S.A.S., Molsheim, France

Details on oral exposure:

A single dose of test item was administered to the appropriate animals by oral gavage on Day 1, using a syringe with a plastic gavage cannula attached. The dose volume for each animal was based on the body weight measurement prior to dosing.
A dose volume of 10 mL/kg body weight was used for each dose. The dosing formulations were stirred continuously during dose administration. Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and
until 3-4 hours after administration of the test item. Water was available.

Doses:

The oral route was selected as it is a possible route of human exposure during manufacture, handling or use of the test item. The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item.

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. The first group was treated at a dose level of 2000 mg/kg. Based on the results, one additional group was dosed at 2000 mg/kg.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture and piloerection were noted for all animals on Day 1.

Applicant's summary and conclusion

Interpretation of results:

other:

Conclusions:

No mortality occurred.

Executive summary:

The oral LD50 value of 03590 in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, 03590 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).