Morpholinium, 4-[2-[2-[(2-hydroxyphenyl)methylene]hydrazinyl]-2-oxoethyl]-4-methyl-, chloride (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guidelines Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-({N'-[(2-hydroxyphenyl)methylidene]hydrazinecarbonyl}methyl)-4-methylmorpholin-4-ium chloride

EC Number:

700-714-9

Cas Number:

1254469-57-2

Molecular formula:

C14H20ClN3O3

IUPAC Name:

4-({N'-[(2-hydroxyphenyl)methylidene]hydrazinecarbonyl}methyl)-4-methylmorpholin-4-ium chloride

Details on test material:

- Name of test material (as cited in study report): Tinocat ES 96000
- Physical state: solid
- Analytical purity: > 99%
- Lot/batch No.: RD173323
- Stability under test conditions: The stability of the test item under storage conditions over the test period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature; under light exclusion; protect against humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight, 178 - 191 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 °C +- 3 °C
- Humidity (%): 30 – 70%
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 3 or 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Aqueous preparation corresponds to the physiological medium.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation. Additionally, at day of death in animals that died or were sacrificed moribund starting with study day 1. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with increasing concentrations over time. Necropsy of all animals that died before as early as possible after death.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal of the first 2000 mg/kg test group was found dead at hour 2 and two animals of the second 2000 mg/kg test group died either immediately after application or at hour 3 resp..
No mortality occurred in the six females administered 300 mg/kg bw.

Clinical signs:

other: Two animals of the first 2000 mg/kg bw test group showed impaired general state, piloerection and dyspnoea only on study day 1 after administration. In the animal that died immediately after the 2-hours reading in the same test group poor general state, d

Gross pathology:

The animal of the first 2000 mg/kg test group which was found dead did not show any
macroscopic pathological findings.
In the second 2000 mg/kg test group edema and light rose discoloration in all lobes of
the lung, dark spotted liver and yellowish discoloration of content in the stomach were
noticed in the animals which died after administration.
There were no macroscopic pathological findings in the animals sacrificed at the end of
the observation period (2000 mg/kg: 3 females; 300 mg/kg: 6 females).