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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20.08.2008 - 03.09.2008

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

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:

male

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.
One, 11-week-old rat female weighing 200 g was used in the sighting study at dose level of 300 mg/kg b.w. Four 9-week-old rat females with the average bodyweight of 187 g were used in the main study at dose level of 300 mg/kg b.w.

Administration / exposure

Details on dermal exposure:

The undiluted test item in single dose of 2000 mg/kg b.w. was applied to dorsal skin of 10 rats (5 males and 5 females). The area of skin treated with the test item was about 42 cm2 (males) and 36 cm2 (females), what was about 10% of total skin area. The test item was applied to gauze patches and then laid on prepared skin. The gauze patches were covered with PCV foil and elastic bandage was used to make circular protecting band. After 24 hours the band and gauze patches were taken off and the residual test item was removed using water.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Clinical signs

Following application of test item, no pathological changes were stated on skin of males and females in the site of test item application. No other clinical signs were stated in animals. All males and females survived 14-day period of observation.

Body weight of animals

Slight body weight loss was stated in two females (No 1 and no 3) during first week of experiment. Lack of body weight gain in female No 3 was recorded during the entire experiment. Slight body weight loss was stated in one female (No 2) during second week of experiment. Normal body weight gain was stated in the remaining animals during the entire experiment.

Post mortem examination

At necropsy no pathological changes in animals (males and females) were stated.

Applicant's summary and conclusion

Executive summary:

Median dermal acute dose (LD50)- On the ground of study one may state that the median dermal acute dose (LD50) for MCPA-2EH active substance is greater than 2000 mg/kg b.w.