kresoxim-methyl (ISO);methyl (E)-2-methoxyimino-[2-(o-tolyloxymethyl)phenyl]acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (limit test at 2000 mg/kg bw)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Limit test (test substance administered at 2000 mg/kg bw)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate

EC Number:

604-351-6

Cas Number:

143390-89-0

Molecular formula:

C18 H19 N O4

IUPAC Name:

methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate

Details on test material:

- Name of test material (as cited in study report): Reg. No. 242 009 (test substance number: 91/180-2)
- Lot/batch No.: N 36 (= III C1); date of manufacturing: 1991-10-23
- Storage condition of test material: room temperature, exclusion of light
- Physical state: solid (powder) / light brown
- Analytical purity: 93.7% (Reversed-Phase - HPLC with UV-Detection)
- Stability under test conditions: the storage stability was guaranteed over the study period
- Other: the homogeneity of the test substance was confirmed by analysis (Reversed-Phase - HPLC with UV-Detection)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CHBB: Thom (SPF); from Dr. K. Thomae GmbH, D-W7950 Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight (200 - 300 g; ±20% of the mean weight).
- Housing: singly in stainless steel wire mesh cages, Type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water
- Acclimation period: at leat one week (clipping of the fur was done at least 15 hours before the beginning of the study)

ENVIRONMENTAL CONDITIONS
The animals were housed in fully air-conditioned rooms. There were no deviations from these ranges which influenced the results of the study.
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 (6:00 - 18:00 / 18:00 - 6:00 hours)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0.5% tylose CB 30.000 CMC (carboxymethyl cellulose) in aqua bidest

Details on dermal exposure:

TEST SITE
- Area of exposure: about 50 cm2 on the dorsal and dorsolateral parts of the animal trunk
- % coverage: not specified
- Type of wrap if used: the bandage consists of four layers absorbent gauze, PH. EUR. Lohmann GmbH & Co. KG and Fixomull Stretch (adhesive fleece), Beiersdorf AG.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of the dressing after 24 hours and rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration (if solution): test substance formulation with vehicle at 50.000 g/100 ml
- Constant volume or concentration used: yes

VEHICLE
see above

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weight shortly before application (Day 0), weekly thereafter and at the end of the study (before the 16-hour fasting period preceeding the necropsy). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any read or moribund animals.
- Necropsy of survivors performed: yes, necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible.
- Other examinations performed: scoring of the skin finding was done according to Draize, JH (1959) by individual readings 30- 60 min after removal of the semiocclusive dressing (day 1), weekly thereafter and at the end of the study (last day of the observation period).

Statistics:

none performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no abnormalities or mortalities at this unique dose level

Mortality:

no mortalities were observed

Clinical signs:

other: only local effects were observed (see Table 1)

Gross pathology:

no pathologic finding noted

Other findings:

only local effects (see Table 1 below)

Any other information on results incl. tables

Table 1: Local effects

Local effects	Number of animals (corresponding days of observation) showing local effects
	Male group	Female group
Very slight erythema	3 (Day 1)	2 (Day 1)
Well-defined erythema	1 (Day 1)	1 (Day 1)
Very slight edema	1 (Day 1)	-

Table 2: Body weight development

Treatment group (mg/kg)	Mean body weight after (for survival animals)
	0 day		7 days		14 days
	Males	Females	Males	Females	Males	Females
2000	270	241	295	245	275	246