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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study similar to guideline (GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

6 animals evaluated

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

GLP compliance:

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:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach, FRG
- Age at study initiation: young adult animals identified by Ear tattoo
- Weight at study initiation: 2.36-2.90 kg for females (4 animals) and 2.23-2.80 kg for males (2)
- Housing: singly in stainless steel cage with wire mesh walk floors; floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): KLIBA Labordiaet 341; Klingentalmuhle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): tap water (ca. 250 ml per animal per day)
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS (fully air-conditioned rooms)
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g; the unchanged solid or semi-solid test substance and has been moistened with aqua bidest (because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible).

Duration of treatment / exposure:

4 hours

Observation period:

because all effets were reversible within 24 hours, the observation period was limited to 72 hours

Number of animals:

6 (4 females and 2 males)

Details on study design:

TEST SITE
- Area of exposure: at least 24 hours before the test, the fur was removed by clipping the dorsal of the trunk of the animal(s). Only animals with healthy intact skin have been used.
- % coverage: not specified; the surface of the test patch was 2.5 cm x 2.5 cm
- Type of wrap if used: the test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was removed at the end of the exposure period with Lutrol (=Polyethylenglycol DAB) and Lutrol/ water (1 : 1).
- Time after start of exposure: 4 hours

SCORING SYSTEM: Table according to OECD Guideline 404 (adopted May 12, 1981) and EEC L 251, B.4. (Sept. 19, 1984); readings were done about 1, 24, 48 and 72 hours after removal of the patch.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all tested animals (6)

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: a slight erythema (score 1) was observed in only one animal 1 hour after treatment, but was fully reversible within 24 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all tested animals (6)

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Based on the irritation scores the test substance is not irritating to the rabbit skin according to the EU and to GHS

Other effects:

no other effects were observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information