Condensation products of fatty acids, tall oil with 2-amino-2-ethylpropanediol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Condensation products of fatty acids, tall oil with 2-amino-2-ethylpropanediol

EC Number:

946-010-7

Molecular formula:

None

IUPAC Name:

Condensation products of fatty acids, tall oil with 2-amino-2-ethylpropanediol

Test material form:

liquid: viscous

Specific details on test material used for the study:

Identification: Alkaterge E
Appearance: Brown viscous liquid
Batch: D598F47BC1
Purity/Composition: UVCB
Test item storage: At room temperature
Stable under storage conditions until: 05 April 2020 (retest date)

Additional information
Test Facility test item number: 208794/A
Purity/Composition correction factor: No correction factor required
Chemical name (IUPAC, synonym or trade name: 4-Ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol,Alkaterge E
CAS number: 68140-98-7
Molecular formula: C23H43NO2
Molecular weight: 365.60
Specific gravity / density: 0.925 (25°C)

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl: WI(Han)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Housing
On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. These housing conditions were maintained unless deemed inappropriate by the Study Director and/or Clinical Veterinarian. The room(s) in which the animals were kept were documented in the study records. Animals were separated during designated procedures/activities. Each cage was clearly labeled.

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 an actual daily mean relative humidity of 49 to 72% (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.

Food
Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures. The feed was analyzed by the supplier for nutritional components and environmental contaminants.

Water
Municipal tap-water was freely available to each animal via water bottles.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Alkaterge E, was administered as received. Adjustment was made for specific gravity of the test item. No correction was made for the purity/composition of the test item.

A single dose of test item was administered to the appropriate animals by dermal application on Day 1. One day before dosing, an area of approximately 5x7 cm on the back of the animals was clipped. The test item was applied in an area of approximately 10% of the total body surface, i.e. approximately 25 cm² for males and 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only. The application period was 24 hours, after which the dressing was removed and the skin cleaned of residual test item using water or an appropriate vehicle.

Duration of exposure:

24 hours

Doses:

2000 m/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

not required

Details on study design:

Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from cage during observation, unless necessary for identification or confirmation of possible findings.

Post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. The observation period was 14 days. All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate), particular attention being paid to the animals during and for the first hour after dosing.

Animals were weighed individually on Day 1 (pre-dose), 8 and 15.

All animals were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture, quick breathing, chromodaccryorrhoea (snout) and/or piloerection were noted for the animals between Days 1 and 6. Scabs (back and left flank) and/or focal erythema (back and left flank) were noted for the animals between Days 2 and 11. G

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 value of Alkaterge E in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

Alkaterge E was administered to five Wistar rats of each sex by a single dermal application at 5000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

 

No mortality occurred. Hunched posture, quick breathing, chromodaccryorrhoea (snout) and/or piloerection were noted for the animals between Days 1 and 6. Scabs (back and left flank) and/or focal erythema (back and left flank) were noted for the animals between Days 2 and 11. General erythema, scales, scabs, thickened area and brown discoloration were seen in the treated skin-area of the animals during the observation period. These local effects were considered not to have affected the conclusion of the study. The body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals.

 

The dermal LD50 value of Alkaterge E in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results, Alkaterge E does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).