methyl (2E)-{2-[(2,5-dimethylphenoxy)methyl]phenyl}(methoxyimino)ethanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP regulations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): X-E-OXIMETHER
- Analytical purity: 98.4%
- Batch No.: 26249/176
- Substance No.: 96/288

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 2.93, 2.96 and 3.23 kg
- Housing: Single in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Tap water, about 250 ml/animal/day
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- 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:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Upper third of the back or flanks
- Type of wrap: The test substance was covered with a test patch and adhesive fleece.


REMOVAL OF TEST SUBSTANCE
- Washing: The substance was removed at the end of the exposure with lutrol and lutrol/water (1:1)

SCORING SYSTEM: According to OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: one animal has a score of "1" at time point 24h and 48 h. All other scores are "0".

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Any other information on results incl. tables

The potential of X-E-Oximether to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 New Zealand White rabbits for 4 hours under semiocclusive dressing.

 

The average score (24 to 72 hours) for irritation was calculated to be 0.2 for erythema and 0.0 for edema. The skin finding, observed in 1 animal was reversible 72 hours after removal of the patch.

 

Thus, under the test conditions chosen and considering findings X-E-Oximether did not give indication of an irritant property to the skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU