(Z)-N-[2-(2-hydroxyethoxy)ethyl]-9-octadecenamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 20, 1996 to April 4, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C8-18 and C18-unsatd., N-(hydroxyethyl)

EC Number:

931-330-1

Molecular formula:

The alkyl chain length of the amide ranges between 8 and 18 carbon atoms

IUPAC Name:

Amides, C8-18 and C18-unsatd., N-(hydroxyethyl)

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Amidet A-111
- Physical state: Cream coloured flakes
- Lot/batch No.: 2020430
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 5-8 wk
- Weight at study initiation: Males - 152 - 182 g, females - 140-156 g
- Fasting period before study: Overnight
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: Rat and mouse expanded diet no. 1, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: Atleast 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 44-65
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2,000 mg/kg in both range-finding and main study

No. of animals per sex per dose:

one in range-finding study and five in main study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of clinical observation: 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 d
- Frequency of weighing: On Days 0, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination

Results and discussion

Preliminary study:

No deaths or clinical signs of toxicity

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

No signs of systemic toxicity

Body weight:

All animals showed an expected gain in body weight except one female which showed reduced body weight gain during the second week of observation

Gross pathology:

No abnormalities noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 of the test substance in rat was found to be >2000 mg/kg.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance to Sprague Dawley rats according to OECD Guideline 401 and EU Method B.1, in compliance with GLP. Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test material as a solution in arachis oil BP at a dose level of 2000 mg/kg. The animals were observed for 14 d after dosing and were then killed and subjected to gross pathological examination. There was no mortality in the study and no signs of systemic toxicity were noted. All animals showed an expected gain in body weight apart from one female which showed reduced body weight gain during the second week. No abnormalities were noted at necropsy. Under the study conditions, the LD50 of the test substance in rat was found to be >2000 mg/kg (Hempstock, 1996).