Methyl O-(4-amino-3,5-dichloro-6-fluoropyridin-2-yloxy)acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Adopted on 1987.

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Adopted on 1984.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl O-(4-amino-3,5-dichloro-6-fluoropyridin-2-yloxy)acetate

EC Number:

407-550-4

EC Name:

Methyl O-(4-amino-3,5-dichloro-6-fluoropyridin-2-yloxy)acetate

Cas Number:

69184-17-4

Molecular formula:

Hill formula: C8 H7 Cl2 F N2 O3 CAS formula: C8 H7 Cl2 F N2 O3

IUPAC Name:

methyl 2-[(4-amino-3,5-dichloro-6-fluoropyridin-2-yl)oxy]acetate

Details on test material:

- Name of test material (as cited in study report): Fluroxypyr methyl ester
- Physical state: dark grey powder
- Analytical purity: 90.8%
- Purity test date: 28.08.1990
- Lot/batch No.: C-3B
- Expiration date of the lot/batch: August 1992
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Kent, England
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 219-251 g
- Housing: individually in metal cages with wire mesh floors
- Diet (ad libitum): Biosure LAD 1
- Water (ad libitum): potable water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 56 (mean)
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 5x5 cm
- % coverage: 10% of the total body surface
- Type of wrap if used: covering with gauze held in place with an impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water

TEST MATERIAL
- Amount(s) applied: 2.38 mL/kg
- Concentration (if solution): 84.2%
- Constant volume used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily / weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths were observed.

Clinical signs:

No clinical signs were observed.

Body weight:

Slightly low bodyweight gains were recorded for two female rats on both Day 8 and 15. All other rats achieved anticipated bodyweight gains throughout the study.

Gross pathology:

Terminal autopsy revealed no macroscopic abnormalities.

Other findings:

There were no signs of dermal reactions at any of the application sites of the test material.

Any other information on results incl. tables

Table 1: Individual and group mean bodyweights (g)
Sex	Animal No.	Bodyweight (g) at
		Day 1	Day 8	Day 15
male	1	251	325	381
	2	246	293	334
	3	250	315	364
	4	251	311	365
	5	237	282	328
	Mean	247	305	354
female	6	242	256	270
	7	250	263	281
	8	240	251	262
	9	219	224	242
	10	232	247	256
	Mean	237	248	262

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information