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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

GLP compliance:

yes (incl. QA statement)

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

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.

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(2002)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues 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: 2.4-2.7 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

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye, which remained untreated, served as control.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The lids were gently held together for about one second in order to prevent loss of the material. The eye was rinsed approximately 24 hours following instillation.

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Details on study design:

0.1 mL of the test item were administered per eye and tested in three animals. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours days after the administration. The eye reactions were observed and registered. 24 hours after administration the eyes were treated additionally with fluorescein and examined.

The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation, reversible after 24 hours. The corneae and irises were not affected by instillation of the test item.

Other effects:

There were no systemic intolerance reactions.

Executive summary:

An acute eye irritation/ corrosion test according to OECD TG 405 was conducted with Mecoprop-P n-octyl ester.

Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation, but proved to be reversible after 24 hours. No signs of irritation were observed 24, 48 and 72 hours after treatment.

There were no systemic intolerance reactions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Validated in vitro studies on skin irritation/corrosion (OECD TG 431 and 439) reveal no irritant/corrosive property for Mecoprop-P n-octyl ester.

 

Regarding in vivo testing, a study on skin irritation/corrosion according to OECD TG 404 was conducted. No signs of irritation could be observed in this study after 24, 48 and 72 hours.

No systemic intolerance reactions were observed.

 

For investigating the ocular irritant property an in vitro human corneal epithelium (HCE) test, as prevalidated in 2004 (van Goethem et. al., Tox in Vitro 20, 2006, 1-17) was performed. Based on this assay no irritant/corrosive property to the eye could be concluded. In vivo, an acute eye irritation/corrosion test according to OECD TG 405 revealed no signs of irritation after 24, 48 and 72 hours. Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation, but proved to be reversible after 24 hours.

No systemic intolerance reactions were observed.

Justification for selection of skin irritation / corrosion endpoint:
Only one in vivo study available

Justification for selection of eye irritation endpoint:
Only one in vivo study available

Justification for classification or non-classification

No classification is warranted for skin or eye irritation/corrosion according to Regulation (EC) No 1272/2008, Annex I.