Acetic acid, 2-[(5-chloro-8-quinolinyl)oxy]-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 August 2013 - 14 November 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

August 1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

May 2008

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF 2-1-2

Version / remarks:

November 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[(5-chloroquinolin-8-yl)oxy]acetic acid

Cas Number:

88349-88-6

Molecular formula:

C11H8ClNO3

IUPAC Name:

[(5-chloroquinolin-8-yl)oxy]acetic acid

Test material form:

solid: particulate/powder

Remarks:

powder

Specific details on test material used for the study:

- Name of test material (as cited in study report): X204558
- Physical state: Tan solid
- Analytical purity: 98.3% ± 0.03% wt/wt
- Purity test date: 14 September 2014
- Lot/batch No.: 2GHB0002
- Storage condition of test material: in its original container at ambient condition

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 8 to 11 weeks
- Weight at study initiation: 222.3 - 291.5 g
- Fasting period before study: Not applicable
- Housing: individually in polypropylene rat cages covered with stainless steel grid top
- Diet ad libitum Teklad certified Global High Fiber Rat/Mice Feed
- Water ad libitum UV sterilized water filtered through Kent Reverse Osmosis water filtration system
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 65 to 66
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From: 28 August 2013 To: 18 September 2013

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 7 × 5 cm. Fur was closely clipped from the dorsal area of the trunk of each rat using a clipper without abrading or damaging the skin 24 hours prior to application of the test item.
- % coverage: 10% of the body surface
- Type of wrap if used: The test item was held in contact with the skin using porous gauze dressing (not more than 8 ply) and a non-irritating tape throughout the 24 hours exposure period to prevent any loss of the test item and also to ensure that the rats did not lick or ingest it.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test item was removed using cotton soaked in distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1111.5 to 1457.5 mg
- For solids, paste formed: moistened with 0.2 mL distilled water

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for signs of toxicity and mortality at 1, 2, 3 and 5 h post-dermal application on the day of dosing (day 0). Subsequently, the rats were observed twice a day for morbidity and mortality
- Necropsy of survivors performed: yes, all animals were subjected to a gross pathological examination consisting of an external examination and opening of abdominal and thoracic cavities
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: The clinical signs were recorded once a day. Individual body weight was recorded prior to dermal application on day 0 and on days 7 and 14 post application.

Statistics:

Not required.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

No treatment related clinical signs were observed

Body weight:

All treated rats showed no adverse effects on body weight

Gross pathology:

External examination of terminally sacrificed male and female rats did not reveal any abnormalities of pathological significance.
Visceral examination of male and female rats sacrificed at termination did not reveal any lesions.

Other findings:

No other findings reported

Any other information on results incl. tables

No further information available

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of X204558 in Wistar rats was found to be greater than 5000 mg/kg bw. Classification according to the CLP Regulation is not required.

Executive summary:

An acute dermal toxicity study was conducted with X204558 (cloquintocet acid), according to OECD 402. A group of Wistar rats (5 males and 5 females) were dermally exposed to X204558 for 24 hours following application at a limit dose of 5000 mg/kg body weight. The required quantity (1111.5 to 1457.5 mg) of test item (moistened with 0.2 mL distilled water) was applied over the clipped area (approximately 7 × 5 cm body surface area) and the rats were observed for a period of 14 days.

There were no treatment-related mortality, clinical signs, changes in body weight or necropsy findings recorded. The acute dermal LD50 of X204558 (cloquintocet acid) in male and female Wistar rats was found to be greater than 5000 mg/kg bw. Based on the results of this study, cloquintocet acid is not classified for acute dermal toxicity according to the CLP Regulation.