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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jun-Jul 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not performed according to GLP but it is similar to the OECD 402 guideline however the substance tested is poorly described.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
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: yellowish liquid
- 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: not determined
- Stability under test conditions: no data
- Storage condition of test material: at room temperature, day light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr A Ivanovas, Kissleg/Allgäu
- Age at study initiation: no data
- Weight at study initiation: male: 220-270 g, female: 200-245 g
- Fasting period before study: no data
- Housing: individually
- Diet: Ssniff R10 (pellets) ad libitum
- Water (e.g. ad libitum): yes
- 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: From: June To: July 1981

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: back, area 5 x 7.5 cm
- % coverage: no data
- Type of wrap if used: aluminium foil and "Elastoplast"


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3 mL / kg
- Concentration (if solution): no data
- Constant volume: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): no data
- Purity: no data
Duration of exposure:
24 h
Doses:
0.82 - 1.0 - 1.21 - 1.47 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day for observations, at day 1, 7 and 15 for weighing
- Necropsy of survivors performed: yes
Statistics:
Finney method

Results and discussion

Preliminary study:
not relevant
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1.26 mL/kg bw
95% CL:
1.15 - 1.39
Mortality:
See table 1
Clinical signs:
Skin effect:
Neither erythem nor oedema was observed.
Clinical signs:
Decrease of motility, abdominal posture of pre-agony.
Body weight:
No effect on body weight gain.
Gross pathology:
No effects in the animal that died in the study.
Animals sacrified at the end of the study:
Dose 1 mL/kg: Pale discoloration of liver and kidneys, bloody aspect of the stomach and intestine content (1 female)
Dose 1.21 mL/kg: Autolysis (1 male), Pale discoloration of liver and kidneys, medium grade hyperemia of the lungs. Bloody aspect of the stomach and small intestine content (2 females)
Dose 1.47 mL/kg: Autolysis (2 males and 5 females), Pale discoloration of liver and kidneys (2 males), medium grade hyperemia of the lungs (2 males). Bloody aspect of the stomach (2 males and 3 females) and small intestine content (2 males).
Other findings:
none

Any other information on results incl. tables

Table 1: Mortality

Time

Control

0.82 mL/kg

1.0 mL/kg

1.21 mL/kg

1.47 mL/kg

Up to 6h

M
F

0/5
0/5

0/5
0/5

0/5
0/5

0/5
0/5

0/5
0/5

6-24h

M
F

0/5
0/5

0/5
0/5

0/5
0/5

0/5
0/5

0/5
0/5

24-48h

M
F

0/5
0/5

0/5
0/5

0/5
1/5

0/5
1/5

4/5
4/5

3-7 d

M
F

0/5
0/5

0/5
0/5

0/5
0/5

1/5
1/5

0/5
1/5

7-14d

M
F

0/5
0/5

0/5
0/5

0/5
0/5

0/5
0/5

0/5
0/5

Total

M
F

0/5
0/5

0/5
0/5

0/5
1/5

1/5
2/5

4/5
5/5

 %    0  0 10   30 90 

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 of quinoline in rat is 1377 mg/kg. Quinoline is harmful in contact with skin according to the 67/548/EEC directive and according to CLP (cat 4).
Executive summary:

A standard dermal acute toxicity method has been performed with quinoline on rat. 5 animals per sex per group were treated by quinoline doses from 0.82 to 1.47 mL/kg bw. In these conditions, the LD50 is 1.26 mL/kg corresponding to 1377 mg/kg bw.