[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

1

Reference substance name:

Amides, C16-18 (even numbered), N-C16-18 (even numbered) alkyl

Molecular formula:

R1-NH-C=O-R2, with R1=C16H33 and C18H37 & R2 = C15H31 and C17H35

IUPAC Name:

Amides, C16-18 (even numbered), N-C16-18 (even numbered) alkyl

Test material form:

solid

Details on test material:

- Chemical registery number : 955-212-4
- Chemical name: Amides, C16-18 (even numbered), N-C16-18 (even numbered) alkyl

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 164 g. Body weight variation did not exceed +/- 20% of the body weight of the initially dosed animals.
- Fasting period before study: Overnight fast immediately before dosing and approximately three to four hours after dosing.
- Housing: suspended solid floor polypropylene cages furnished with wood chippings.
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): Fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light and twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Arachis oil was used because the test item did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED:
2,000 mg/kg

Doses:

In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
In the absence of toxicity at the dose level of 300 mg/kg, an additional dose level of 2,000 mg/kg was included.

No. of animals per sex per dose:

300 mg/kg - 1 animal
2,000 mg/kg - 5 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 1/2, 1, 2 and 4 hours after dosing, and then daily for fourteen days. Individual body weights were recorded on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: external examination, opening abominal and thoracic cavities.

Results and discussion

Preliminary study:

There was no mortality; no signs of systemic toxicity were noted during the observation period.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test material in female Wistar strain rat was estimated to be greater than 2,000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths.
There were no signs of systemic toxicity.
All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).