Nonanamide, N,N-dimethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 October 2016 to 17 December 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Acute Oral Toxicity - Acute Toxic Class Method" adopted on 17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

1

Reference substance name:

N,N-dimethylnonanamide

EC Number:

612-975-5

Cas Number:

6225-08-7

Molecular formula:

C11H23NO

IUPAC Name:

N,N-dimethylnonanamide

Details on test material:

- Name of test material (as cited in study report): N,N-Dimethylnonanamide
- Synonyme: Genagen PA

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and batch No.of test material: 112-2016-11 D
- Expiration date of the batch: May 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)
- Solubility of the test substance in the vehicle: Corn oil (200 mg/mL)

FORM AS APPLIED IN THE TEST: Liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: 167.21 g to 177.61 g
- Fasting period before study: overnight (16 to 18 hours) prior to dosing
- Housing:Three animals were housed in standard polypropylene cage (Size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet (Sterilizable) manufactured by Envigo
- Water (e.g. ad libitum):Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier
- Acclimation period:Start: 28 October 2016; End: 09 November 2016

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0°C to 22.5°C
- Humidity (%): 50% to 65%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle

IN-LIFE DATES: From: 28 October 2016; To: 24 November 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Step-I & Step-I Confirmation: 30 mg/mL;
Step-II & Step-II Confirmation: 200 mg/mL;
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle:As per the in-house solubility/suspendibility test, test item formed a suspension in corn oil.
- batch no: C-167
- Purity: Pure

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

DOSAGE PREPARATION: A small quantity of vehicle was added to test item and mixed well and thereafter the formulation was transferred into measuring cylinder. Again, a small quantity of vehicle was added to the mortar and rinsed and transferred into the measuring cylinder. Finally the volume was made up to required quantity with vehicle to get a desired volume

CLASS METHOD
- Rationale for the selection of the starting dose: As no information on LD50 of Genagen PA/ N,N-Dimethylnonanamide in rats was available, a starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight

Doses:

Step-I and Step I confirmation: 300 mg/kg body weight;
Step-II and Step II confirmation: 2000 mg/kg body weight

No. of animals per sex per dose:

3 females per step per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily once for clinical signs and weekly body weights
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality at both tested doses (300 and 2000 mg/kg body weight)

Clinical signs:

other: No clinical signs of toxicity observed at both tested doses (300 and 2000 mg/kg body weight)

Gross pathology:

No gross pathological changes were observed in any of the animals at 300 mg/kg body weight in Step I and Step I confirmation and 2000 mg/kg body weight in Step II and Step II confirmation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.