Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride

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 guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2015

Materials and methods

Test guideline

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride

EC Number:

941-484-1

Molecular formula:

not possible

IUPAC Name:

Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks old (age at the beginning of the study)
- Weight at study initiation: females:
Step 1: animals no.: 1 - 3: 150 - 166 g
Step 2: animals no.: 4 - 6: 149 - 163 g
Step 3: animals no.: 7 - 9: 165 - 178 g
- Fasting period before study: 16 to 19 hours
- Housing: 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 55 +- 10%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.03 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: soluble in water
- Lot/batch no. (if required): 260813_1 (AlleMan Pharma)
- Purity: ad injectionem

Doses:

2000 and 300 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: at 30 minutes and 4 h after dosing and once daily thereafter
- Frequency of weighing: day 1 (prior to dosing), day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In absence of
gross pathological changes no tissues were preserved for a possible histopathological evaluation.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off

Mortality:

Mortality was observed at all dose levels.
All mortalities occurred on day one after administration.

Clinical signs:

other: The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were piloerection and opisthotonus. The most relevant clinical findings in the animals treated with the test item at a dose of 300 mg/kg bw were reduc

Gross pathology:

With the exception of acute 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

Starting Dose (mg/kg bw)	Number of Animals	Number of Intercurrent Deaths	LD50 Cut-Off (mg/kg bw)
2000	3	3	500
300	6	1

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The median lethal dose of the substance after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 500 mg/ kg bw.