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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
unkempt fur, hunched posture, paleness of extremities, increased lacrymation, lethargy and ataxia of grade minimal to medium to high.
Body weight:
Body weight gain similar to the control
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.