Reaction mass of N-(hydroxymethyl)hexadecan-1-amide and N-(hydroxymethyl)stearamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27.09.-12.10.17

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

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:

Reaction mass of N-(hydroxymethyl)hexadecan-1-amide and N-(hydroxymethyl)stearamide

EC Number:

911-553-0

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of N-(hydroxymethyl)hexadecan-1-amide and N-(hydroxymethyl)stearamide

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: MAT- Consulting, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: at least 8-12 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): food was offered according to guideline
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.4 ± 0.2 °C
- Humidity (%): 54.4 ± 1.9 %
- Air changes (per hr): central air-conditioning
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required): L63417
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 / 3

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: 0.5, 1, 2, 4 hours after administration
- Necropsy of survivors performed: yes
- Other examinations performed: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.

Clinical signs:

other: no

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item N-(hydroxymethyl) stearamide is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item N-(hydroxymethyl) stearamide when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

A limit dose of 2000 mg/kg body weight was used as a starting dose. Two groups of 3 females were dosed. All 6 females survived the limit dose. The limit dose of 2000 mg/kg body weight did not cause death or evident signs of toxicity. The body weights of all animals were increasing during the study. No body weight losses were observed between the first and second week after administration. During necropsy, no macroscopic findings were observed.

The LD50 of the test item N-(hydroxymethyl) stearamide is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item N-(hydroxymethyl) stearamide is according to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight according to Regulation (EU) Nr. 1272/2008 (CLP), after single oral administration to Wistar rats.