Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 14, 1990 - November 28, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability 2 is assigned because the study is conducted according to OECD TG 401, without deviations that influence the quality of the results but predating GLP requirements

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

EC Number:

916-241-8

Molecular formula:

C13H15N

IUPAC Name:

Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Isobutylquinoleine D 49560
- Chemical name: Quinoleine, 6-(1-methylpropyl) (main constituent) Quinoleine, 8-(1-methylpropyl) (11-15%)
- Physical state: liquid
- Storage condition of test material: At room temperature (about 20°C); protected from light

Test animals

Species:

rat

Strain:

other: Fü-Albino outbred stock Ibm:RORO (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Biological Research Laboratories (BRL), CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: No data
- Weight at study initiation: males: 116.0 - 128.0 g; females: 116.0 - 121.9 g
- Fasting period before study: overnight before treatment till 4 hours after treatment
- Housing: group housing 3 animals per cage in macrolon cages type III
- Diet: free access to KLIBA 25-343 (batch 76/90), complete rodent maintenance diet
- Water: free access to tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15 - 20 cycles
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250, 320 and 400 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: from a pilot study with the substance it was concluded that the LD50 could be near or above 2000 mg/kg.

Doses:

0, 1250, 1600 and 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed 30 minutes, 1, 2 and 4 hours after application and thereafter daily
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by CO2 asphyxia, necropsied and subjected to examination for gross pathological changes.
- Body weights: Individual body weights were recorded immediately before treatment and then on the 7th and 14th day of the observation period.

Statistics:

Not performed.

Results and discussion

Preliminary study:

From a pilot study with the substance it was concluded that the LD50 could be near or above 2000 mg/kg.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observed.

Clinical signs:

other: At the dose level of 1250 mg/kg, the males showed moderate to trace sedation during the first 2 hours after treatment, whereas the females remained without symptoms. In general, the observed symptoms were mild and dissappeared completely within 4 hours af

Gross pathology:

No signs of gross pathological changes were found necropsy, exept in one male in the 2000 mg/kg dose group, where the stomach was partially grown together with rate and liver tissue.

Any other information on results incl. tables

The effect seen in the stomach of the one male may be indicative for irritation of the test substance.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study with male and female rats, performed according to OECD 401 test guidelines, an LD50 >2000 mg/kg bw was determined.

Executive summary:

Sec Butyl Quinoline was tested in an acute oral toxicity study with male and female rats, performed according to the OECD 401 guideline. At the dose level of 1250 mg/kg, the males showed moderate to trace sedation during the first 2 hours after treatment, whereas the females remained without symptoms. In general, the observed symptoms were mild and dissappeared completely within 4 hours after treatment, exept in one male and one female in the 1600 mg/kg dose group, which still showed symptoms like gasping and/or sedation 24 hours after tretament. No signs of gross pathological changes were found necropsy, exept in one male in the 2000 mg/kg dose group, where the stomach was partially grown together with rate and liver tissue, which may indicate some irritation of the substance. The LD50 was established to be >2000 mg/kg bodyweight.