2-ethylhexyl (4-chloro-2-methylphenoxy)acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03.09.2008 - 17.09.2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl (4-chloro-2-methylphenoxy)acetate

EC Number:

249-636-2

EC Name:

2-ethylhexyl (4-chloro-2-methylphenoxy)acetate

Cas Number:

29450-45-1

Molecular formula:

C17H25ClO3

IUPAC Name:

2-ethylhexyl (4-chloro-2-methylphenoxy)acetate

impurity 1

Reference substance name:

(4-chloro-2-methylphenoxy)acetic acid

EC Number:

202-360-6

EC Name:

(4-chloro-2-methylphenoxy)acetic acid

Cas Number:

94-74-6

Molecular formula:

C9H9ClO3

IUPAC Name:

(4-chloro-2-methylphenoxy)acetic acid

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Wistar rats (outbred) used in experiment came from conventional culture of Institute of Occupational Medicine, Łódź.
Prior to the start of dosing, the animals were quarantined and observed daily for at least 5 days. The general medical-veterinary examination was performed on day of introduction of animals to quarantine. Detailed medical veterinary examination was performed prior to the beginning of experiment. Animals without any clinical signs were introduced to the experiment. All animals were individually marked.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item was administered to females once in form of emulsion in corn-oil with the aid of ball ended feeding needle affixed to the top of syringe in volume 0.5 mL of emulsion per 100 g of rat body weight. 1 ml of administered emulsion contained 60 mg of test item (dose 300 mg/kg b.w.).

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Clinical signs

Following administration of test item in dose 300 mg/kg b.w. to one rat female in the sighting study, the following signs of toxicity were stated:

·        wavering gait – from 3^rdhour after administration to 2nd day of observation;

·        paresis of hind limbs – from 4^thhour after administration of test item to 1st day of observation;

·        vocalization (animal squeezed during catching) – from 5th hour after administration to 1^stday of observation;

·        slight decrease in locomotor activity on 2^ndday of observation.

The female survived 14-day period of observation.

Following administration of test item in dose 300 mg/kg b.w. to next four rat females in the main study, the following signs of toxicity were stated in all females:

·        wavering gait from 1st to 5th hour after administration (females No 2, No 3 and No 4) and to 1st day of observation (female No 5);

·        paresis of hind limbs – during 4th and 5^thhour after administration of test item;

·        slight decrease in locomotor activity – during 2^ndhour after administration of test item and on 1^stday of observation; distinct decrease in locomotor activity – from 3^rdto 5^thhour after administration of test item; dejection – from 4^thto 5^thhour after administration of test item.

All females survived 14-day period of observation.

Post mortem examination

At necropsy left-handed swelling and fragility of liver was stated in female No 1, what could be connected with individual sensitivity of this female to test item. No pathological changes were stated in the remaining rats.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

On the ground of the study one may state, that MCPA-2EH may be classified to category 4 – according to the Globally Harmonized System (GHS).