Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 May 1981
Reliability:
1 (reliable without restriction)

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)
Version / remarks:
12 May 1981
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
The test substance "HYDROXYQUINOLINE" was supplied by AAGRUNOL – STÄHLER, Pflanzenschutzunion GmbH & Co. KG., D-2160 Stade/Elbe. This product is a whitish-grey, coarse crystalline substance, which was supplied in a paper bag.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Paderborn
- Weight at study initiation: aaproximately 170 g
- Housing: individual cages
- Diet (e.g. ad libitum): ad libitum standard laboratory diet (supplied by Altromin
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C,
- Humidity (%): 50% - 60%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
For the purpose of the test, the substance was crushed and heavily moistened before being applied to the shaved backs of the rats. The product was easy to apply as a paste. The rats behaved somewhat more calmly than normal following application, which can be attributed to the occlusive dressing.
Duration of exposure:
24h
Doses:
0, 5mg/kg, 10mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
In order to apply the substance optimally and achieve good skin contact, the rats were shaved down to the bare skin along their backs. The entire trunk was wrapped in 2 layers of gauze and the heavily moistened substance was applied to the shaved area. The treated area was covered with a thin plastic film, over which a Stülpa bandage was applied. To prevent slippage, the entire trunk was secured with Leukoplast adhesive plaster; at the same time, this prevented any oral intake or evaporation of the moistened substance. This occlusive dressing was left in place on the rats for 24 hours. Then the rats were carefully "unwrapped" and cleaned with a warm, moist cloth. They were dried with a warm air device and then replaced in their cages. Following the dermal application, the rats were kept in individual cages and observed for 14 days, the criteria for assessment being the symptoms of toxicosis, clinical behaviour and mortality rate. On the 14th day post administration, the rats were killed, dissected and examined macroscopically for anatomical-pathological changes.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
Group Dose/Test substance 24 hours 7 days 14 days
I = control none 0/10 0/10 0/10
II 5 mg/kg 0/10 0/10 0/10
III 10 mg/kg 0/10 0/10 0/10
Clinical signs:
No treatment related clinical findings were observed
Body weight:
Group Ave. starting weight (g) Ave. weight after 14 days
I = control 169.8 ± 10.11 194.2 ± 18.08
II 171.3 ± 12.27 194.1 ± 19.24
III 171.3 ± 11.62 197.0 ± 22.72

In test groups I – III, no differences in weight increase were observed up to 14 days post administration.
Gross pathology:
The final dissection did not reveal any macroscopic anatomical-pathological findings in the abdominal cavity, chest cavity or cranial cavity. Furthermore, the areas of skin to which the substance was applied did not show any signs of intolerance on the underside.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item quinol-8-ol is higher than 10 000 mg/kg body weight after exposure to Wistar rats.
Executive summary:

In order to apply the quinolin-8 -ol optimally (0, 5 and 10g/mg bw) and achieve good skin contact, the rats were shaved down to the bare skin along their backs. The entire trunk was wrapped in 2 layers of gauze and the heavily moistened substance was applied to the shaved area. The treated area was covered with a thin plastic film, over which a Stülpa bandage was applied. This occlusive dressing was left in place on the rats for 24 hours. Following the dermal application, the rats were kept in individual cages and observed for 14 days, the criteria for assessment being the symptoms of toxicosis, clinical behaviour and mortality rate. On the 14th day post administration, the rats were killed, dissected and examined macroscopically for anatomical-pathological changes. No mortality up to 14 days post administration was observed. The final dissection did not reveal any macroscopic anatomical-pathological findings in the abdominal cavity, chest cavity or cranial cavity. In the activity test during the follow-up observation period, even the rats in the highest dosage group displayed no clear deviation from normal behaviour. Weight development and feed intake were also normal