N-(carboxymethyl)-3-[(2Z)-docos-2-enoylamino]-N,N-dimethylpropan-1-aminium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23 September 2002 to 10 October 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-conform study under GLP without deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report):DV6850
- Substance type: powder
- Physical state: solid
- Analytical purity: 83.7%
- Lot/batch No.: R0332-52C
- Expiration date of the lot/batch: 2003/09/30
- Storage condition of test material: ca 4°C in the dark in dry conditions

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK. Ltd., Bicester, Oxon, England
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 85-108g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately four hours after dosing
- Housing: In groups of three rats of the same sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): drinking water at libitum
- Acclimation period: minimum period of five days prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): relative humidity 40 - 70%.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): controlled by means of a time switch to provide 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg body weight
- Justification for choice of vehicle: soluble in water


MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to the guideline, start with 2000mg/kg if no of low toxicity is expected

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations twice daily, Weighing on day 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: mortality clinical signs, body weight, macroscopic examination

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single oral gavage dose of DV6850 to a group of six rats (three males and three females) at a dose level of 2000 mg/kg bodyweight.

Clinical signs:

other: No clinical signs of reaction to treatment were observed in any animal throughout the duration of the study.

Gross pathology:

No abnormalities were revealed at the macroscopic examination at study termination on Day 15.

Any other information on results incl. tables

Individual and group mean bodyweights (g)

Dose (rng)kg)	Sex	Animal Number	Bodyweight (g) at Day
			1*	8	15
2000	Male	GG4	103	153	187
		GG5	108	161	200
		GG6	104	166	218
	Mean		105	160	202
	Female	GGI	86	128	145
		GG2	92	138	164
		GG3	85	132	159
	Mean		88	133	156

* Prior to dosing

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal oral dose to rats of DV6850 was demonstrated to be greater than 2000 mg/kg bodyweight in accordance with OECD Guideline No. 423. DV6850 is in accordance with DSD (Directive 67/548/EEC) or CLP Regulation (EC) No 1272/2008 "unclassified" and will not require labelling

Executive summary:

This study was performed to assess the acute oral toxicity of DV6850 to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 96/54/EEC (Official Journal No, L248, 30,9,96). Part B, Method B.1 tris, "Acute toxicity (oral) - acute toxic class method" and OECD Guideline for Testing of Chemicals No.423 “Acute Oral Toxicity - Acute Toxic Class Method” Adopted 22 March 1996.

A group of three fasted female rats received a single oral gavage dose of the test substance, formulated in water for irrigation, at a dose level of 2000 mg/kg. As results at this dosage indicated the acute lethal oral dose of the test material to be greater than 2000 mg/kg bodyweight, in compliance with the study guidelines, a group of three fasted males was dosed at 2000 mg/kg to confirm results at this dosage and complete the study.

All animals were killed as scheduled and examined macroscopically on Day 15, the end of the observation period. No clinical signs of reaction to treatment were observed in any animal throughout the duration of the study. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were revealed at the macroscopic examination at study termination on Day 15.

The acute lethal oral dose to rats of DV6850 was demonstrated to be greater than 2000 mg/kg bodyweight. DV6850 is in accordance with DSD (Directive 67/548/EEC) or CLP Regulation (EC) No 1272/2008 "unclassified" and will not require labelling.