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EC number: 225-814-5 | CAS number: 5096-13-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-10-07 to 2017-01-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-Benzyl-3-carbamoyl-pyridinium, chloride
- Cas Number:
- 5096-13-9
- Molecular formula:
- C13H13ClN2O
- IUPAC Name:
- 1-Benzyl-3-carbamoyl-pyridinium, chloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
* step 1: 187 – 193 g;
* step 2: 158 – 173 g
* step 3: 163 – 174 g
- Fasting period before study: 16-19 hours
- Housing: Full barrier in an air-conditioned room
- Diet: ad libitum, free access to Altromin 1324 maintenance diet for rats and mice
- Water: ad libitum, free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE (Aqua ad injectionem, AlleManPharma, expiry date: 10/2018)
- Concentration in vehicle: 0.2 g/mL for 2000 mg/kg dose (first step), 0.0312 g/mL and 0.032 g/mL for 300 mg/kg dose (second and third step)
- Amount of vehicle (if gavage): 10 mL/kg bw (feeding tube)
- Justification for choice of vehicle: this vehicle was chosen due to its non-toxic characteristics
- Lot/batch no.: 511535
- Purity: pure
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
The test item was administered at a single dose by gavage using a feeding tube.
DOSAGE PREPARATION:
To consider purity of the active component, a correction factor of 1.04 was adopted.
The test item was weighed out into a tared plastic vial on a precision balance. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.
For all animals of the first step, 2.08 g of the test item was dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For all animals of the second step, 0.312 g of the test item was dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 300 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For all animals of the third step, 0.320 g of the test item was dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 300 mg/kg body weight at a dose volume of 10 mL/kg body weight.
Dose formulations were made shortly before each dosing occasion.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
It is the principle of the acute toxic class method that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test item to enable its classification. The item is tested using a stepwise procedure with up to four fixed doses. Absence or presence of compound-related mortality of the animals dosed at one step will determine the next step.
This study provides information both for hazard assessment purposes and for hazard classification purposes. Results enable compounds to be ranked in different classification systems. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- dose group 2000 mg/kg bw: 3;
dose group 300 mg/kg bw: 6 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days; animals were observed for general clinical signs, morbidity and mortality
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. All abnormalities were recorded. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes, at the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation. - Statistics:
- N.A.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The starting dose was selected to be 2000 mg/kg body weight. Compound-related mortality was recorded for 2 animals (out of 3 animals) of step 1. Based on the results and according to the acute toxic class method regime, a second step was performed at a dose of 300 mg/kg body weight. No compound-related mortality was recorded for any animal of step 2. Based on these results and according to the acute toxic class method regime, a third step was performed at a dose of 300 mg/kg body weight. No compound-related mortality was recorded for any animal of step 3. Based on these results and according to the acute toxic class method regime no further testing was required.
- Clinical signs:
- See Table 1 in section "Any other information on results incl. tables".
- Body weight:
- None of the animals showed weight loss during the observation period (see Table 2 in section "Any other information on results incl. tables").
- Gross pathology:
- With the exception of acut injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Clinical Signs
Table 1: Clinical Signs - Individual Data
Step |
Animal No. /Sex |
Starting Dose [mg/kg bw] |
Time Point |
Observations |
1 |
1 /Female |
2000 |
0 – 10 min |
Moderately reduced spontaneous activity, prone position, slow movements, half eyelid closure. |
10 – 60 min |
Moderately reduced spontaneous activity, prone position, slow movements, severe ataxia, half eyelid closure, muscle twitches. |
|||
60 – 120 min |
Moderately reduced spontaneous activity, slow movements, severe ataxia, half eyelid closure, hunched posture. |
|||
120 – 180 min |
Moderately reduced spontaneous activity, hunched posture, slightly piloerection, half eyelid closure. |
|||
180 – 240 min |
Slightly reduced spontaneous activity, hunched posture, slightly piloerection, half eyelid closure. |
|||
240 min – d 15 |
nsf |
|||
2 & 3 / Female |
2000 |
0 – 10 min |
Moderately reduced spontaneous activity, prone position, slow movements, half eyelid closure. |
|
10 – 30/35 min |
died spontaneously |
|||
|
4 – 9 / Female |
300 |
0 min – d 15 |
nsf |
bw = body weight; d = day (day 1 = day of administration); h = hour(s); min = minute(s); nsf = no specific findings
Body Weight Development
Table 2: Absolute Body Weights in g and Body Weight Change in %
Step |
Animal No./ Sex |
Starting Dose [mg/kg bw] |
BW [g] |
BW Change in comparison to Day 1 [%] |
||
Day 1 |
Day 8 |
Day 15 |
Day 15 |
|||
1 |
1 / Female |
2000 |
187 |
216 |
210 |
12 |
2 / Female |
2000 |
193 |
Died spontaneously |
- |
||
3 / Female |
2000 |
187 |
- |
|||
2 |
4 / Female |
300 |
158 |
192 |
203 |
28 |
5 / Female |
300 |
173 |
200 |
205 |
18 |
|
6 / Female |
300 |
166 |
188 |
197 |
19 |
|
3 |
7 / Female |
300 |
163 |
186 |
193 |
18 |
8 / Female |
300 |
163 |
197 |
214 |
31 |
|
9 / Female |
300 |
174 |
198 |
211 |
21 |
BW = body weight
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 value in rats after single oral application of 1-Benzyl-3-carbamoyl-pyridinium, chloride is 1000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (OECD 423) three female Wistar rats were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg bw in a first step. In the second and third step three females each were dosed with 300 mg/kg bw. The test item was dissolved in aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg. Animals were observed for 14 days. Two out of three animals treated with the test item at a dose of 2000 mg/kg died spontaneously on the day of treatment within 30 minutes after dose administration. The third animal of this dose step and all animals treated with the test item at a dose of 300 mg/kg survived until the end of the study. While animals treated with 300 mg/kg bw did not show test-item related signs of toxicity, the most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, prone position, slow movements, ataxia, hunched posture, muscle twitches, piloerection, half eyelid closure. All symptoms recovered within up to 1 day post dose in the surviving animal. Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal. Based on the results the median lethal dose of the test item is 1000 mg/kg bw.
On the basis of the test results given below and in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008 the substance should be classified into Category 4.
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