Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate

EC Number:

266-358-7

EC Name:

Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate

Cas Number:

66423-13-0

Molecular formula:

C18H27ClO3

IUPAC Name:

octyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate

Constituent 2

Reference substance name:

Mecoprop-P n-octyl ester

IUPAC Name:

Mecoprop-P n-octyl ester

Constituent 3

Reference substance name:

Preventol B5

IUPAC Name:

Preventol B5

Constituent 4

Reference substance name:

R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, octyl ester

IUPAC Name:

R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, octyl ester

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 4.5 - 5.5 months
- Weight at study initiation: 2.1-2.4 kg
- Housing: singly in cages measuring 380 mm x 425 mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönwalde, Germany)
- Diet and water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The surrounding untreated skin served as a control.

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

Approximately 24 hours before the test, fur was removed by shaving the dorsal area of the animals’ trunk. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used. A dose of 0.5 mL per animal was applied to the test site (area: approx. 6 cm²). The surrounding untreated skin served as a control. The test item was applied to the test site and covered with a gauze patch which was held in place with non-irritating tape for the duration of the exposure period (semiocclusive conditions). The exposure time was 4 hours. During the exposure the animals were kept in comfortable restrainers. After the 4-hour exposure period the patch was removed and the skin sites were evaluated. Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal.

For reasons of animal welfare a stepwise approach was followed:
Initial test: As there was no evidence of the test item producing severe irritancy or corrosion by the test item, a single patch was applied to one animal for 4 hours.
Confirmatory test: As no corrosive or severe irritant effects were observed in the initial test, 2 further animals were employed 24 hours after start of the initial test.

REMOVAL OF TEST SUBSTANCE: No residual test item had to be removed as no test item was left on the skin after removal of the patch.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

None of the three rabbits exposed for 4 hours to 0.5 mL test item/patch (semi-occlusive conditions) showed any skin reaction.

Other effects:

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

An acute dermal irritation/corrosion test according to OECD TG 404 was conducted with Mecoprop-P n-octyl ester. No signs of irritation could be observed after 24, 48 and 72 hours postexposure-time. There were no systemic intolerance reactions.