7-(4-ethyl-1-methyloctyl)quinolin-8-ol

Endpoint summary

Description of key information

One key study is available, the study was performed in accordance with a suitable guideline (OECD 423) and in accordance with GLP.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Nov 2018 - 28 Nov 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / 1702-18-01/O
- Expiration date of the lot/batch: 25/03/2021
- Purity test date: 26/03/2018


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature (20 ± 5 °C); Keep away from light
- Stability under test conditions: stable

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dobra Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 187-210 g
- Fasting period before study: overnight
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning. Sanitation was performed according to the standard operation procedures.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ° C
- Humidity (%): 50-60 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark cycle

IN-LIFE DATES: From: 05/11/2018 To: 28/11/2018

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.7 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behavioural observations

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period in any of the testing animals

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Table 1 Clinical Observation

Sex	Dose	ID	Administration Result	Clinical Observation
♀	2000 mg/kg	1	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		2	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		3	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		4	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		5	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		6	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period

 

Table 2 Body Weight

Sex	Dose	ID	Body Weight (g)			Body Weight Difference (g)
			Initial	Week 1	Week 2	Week 1-Initial	Week 2-Initial	Week 2-Week 1
♀	2000 mg/kg	1	204	208	209	4	5	1
		2	210	215	229	5	19	14
		3	204	211	213	7	9	2
		4	188	195	197	7	9	2
		5	187	206	207	19	20	1
		6	188	203	206	15	18	3

Table 3 Necropsy Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
♀	2000 mg/kg	1	no findings	♀	2000 mg/kg	4	no findings
		2	no findings			5	no findings
		3	no findings			6	no findings

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item 7-(4-ethyl-1-methyloctyl)quinolin-8-ol is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Executive summary:

The test item 7-(4-ethyl-1-methyloctyl)quinolin-8-ol was administered to 6 female Wistar rats at a limit dose of 2000 mg/kg. All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.The limit dose did not cause death or evident signs of toxicity. During the follow up period, no other signs of intoxication, change of health, nor any other adverse reactions were displayed. The body weight of animals mildly increased during the study.The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The OCED 423 study has been assigned as Klimisch reliability 1.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The LD50 was found to be >2000 mg/kg bw and as such in accordance with Regulation (EC) No.1272/2008 (EU CLP) the substance is not classified.