Quinoline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not performed according to GLP but it is similar to the OECD 401 guideline however the substance tested is poorly described.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study performed before the GLP creation

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Quinoline

EC Number:

202-051-6

EC Name:

Quinoline

Cas Number:

91-22-5

Molecular formula:

C9H7N

IUPAC Name:

quinoline

Details on test material:

- Name of test material (as cited in study report): 110.831
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schering AG, Berlin
- Age at study initiation: no data
- Weight at study initiation: male: 110-130 g; female: 110-125 g
- Fasting period before study: yes for 16 hour
- Housing: 5 animals/ cage
- Diet: Ssniff (pellets)
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

0.10; 0.16; 0.25; 0.40 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

other: yes, receiving 40 mL/kg bw of a solution of CMC at 0.5%

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data

Statistics:

LD50 calculation based on Kärber formula and Weil method.

Results and discussion

Preliminary study:

not relevant

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.24 mL/kg bw

95% CL:

0.18 - 0.32

Mortality:

See the table

Clinical signs:

other: unkempt fur, hunched posture, paleness of extremities, increased lacrymation, lethargy and ataxia of grade minimal to medium to high.

Gross pathology:

Sacrified animal at the end of the study:
Hyperemia of medium grade, hemorrhagic edema of the lungs of minimal grade, apparent lobular contour of the liver parenchym which was loam-coloured, swelling of the liver parenchym, punctiform hemorrhagic erosion of the glandular stomach mucous membrane, bloody stomach content depending on the dose, petechial bleeding in the non glandular mucous membrane of the stomach, minimal to medium grade hyperemia of the duodenum mucous membrane with bloody gut content depending on the dose.

Animals dead during the study:
Hyperemia of minimal to medium grade, hemorrhagic edema of the lungs of minimal grade, minimal to medium grade hyperemia of the liver with apparent lobular contour and swelling of the parenchym.

Other findings:

none

Any other information on results incl. tables

Dose (mL/kg bw)	Sex	No of animals	No of dead animals
Control	M F	5 5	0 0	0%
0.10	M F	5 5	1 0	10%
0.16	M F	5 5	2 0	20%
0.25	M F	5 5	3 2	50%
0.40	M F	5 5	5 4	90%

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of quinoline in the rat is 262 mg/kg bw, It is considered as harmful according to the 67/548/EEC directive and toxic cat 3 according to CLP

Executive summary:

A standard acute oral toxicity method has been performed with quinoline on rat. 5 animals per sex per group were treated by quinoline doses from 0.10 to 0.40 mL/kg bw. In these conditions, the LD50 is 0.24 mL/kg corresponding to 262 mg/kg bw.