9-Decenamide, N,N-dimethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 February 2014 to 24 February 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OPPTS 870.1100 and OECD 425 test guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyldec-9-enamide

EC Number:

806-919-0

Cas Number:

1356964-77-6

Molecular formula:

C12H23NO

IUPAC Name:

N,N-dimethyldec-9-enamide

Test material form:

other: clear colourless liquid

Details on test material:

- Name of test material (as cited in study report): MET-10U
- Physical state: clear colourless liquid
- Analytical purity:
- Lot/batch No.: 5104-014-006 Dec. 5, 2013

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Indianapolis, Indiana
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 203 - 257 g
- Fasting period before study: overnight
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Purina rat chow, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

IN-LIFE DATES: From: 04 February 2014 To: 24 February 2014

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.475 ml

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

Doses:

2000, 550, 175 mg/kg

No. of animals per sex per dose:

3, 4, 3, females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed frequently on day of dosing and dailt thereafter for 14 days. Bodyweights taken on Days 1, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 was calculated according to the Agency's developed software package (AOT425StatPgm) for performing the test and calculation of the LD50.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

550 mg/kg bw

Based on:

test mat.

95% CL:

265.4 - 1 520

Mortality:

3 of 3 animals dosed with 2000 mg/kg died prematurely, 2 of 4 animals dosed with 550 mg/kg died prematurely, there were no premature mortalities in 3 animals dosed with 175 mg/kg.

Clinical signs:

other: Clinical signs were observed on the first day of dosing in all animals dosed with 550 or 2000 mg/kg.

Gross pathology:

No gross observations except for stomach and GI tract distended with gas and fluid in one animal dosed with 2000 mg/kg and one animal dosed with 550 mg/kg.

Any other information on results incl. tables

Results for the individual animals are given in the attached document.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US OSHA

Conclusions:

The statistical estimated acute oral LD50 was determined to be 550 mg/kg body weight and a 95% PL confidence interval of 265.4 mg/kg to 1520 mg/kg. Therefore the substance would be classified EPA Toxicity Category III for acute oral toxicity. According to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, the substance is classified as Category 4.

Executive summary:

Introduction

The substance was tested for acute oral toxicity in accordance with OPPTS Guidelines and the OECD 425 'Up and Down Method'.

Methods

The substance was administered by gavage at various dose levels according to the Up and Down procedure to female rats. Dose levels of 2000, 550 and 175 mg/kg were administered according to the software package AOT 425StatPgm.

Results

The statistical estimated acute oral LD50 was determined to be 550 mg/kg body weight and a 95% PL confidence interval of 265.4 mg/kg to 1520 mg/kg.

Conclusion

The substance would be classified as EPA Toxicity Category III for acute oral toxicity. According to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, the substance is classified as Category 4.