Propanoic acid, 2-(4-chloro-2-methylphenoxy)-, 2-ethylhexyl ester, (2R)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Version / remarks:

EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation:Human and Domestic Animals 81-2 Acute dermal toxicity study, revised edition November 1984

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate

EC Number:

630-324-3

Cas Number:

861229-15-4

Molecular formula:

C18H27ClO3

IUPAC Name:

2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 9 to 14 weeks
- Weight at study initiation: 2.2 to 2.9 kg
- Fasting period before study:
- Housing:
- Diet: ad libitum, Standard Laboratory Diet (SDS Rabbit Diet SQC)
- Water: ad libitum
- Acclimation period: 7days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21°C
- Humidity (%): mean 53%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: hair was clipped one day prior treatment, application on 50 mm x 50 mm area on dorso-lumbar region
- % coverage: 10% of total body surface
- Type of wrap if used: treated area covered promptly with gauze, which was held in place with an impermeable dressing encircled firmly around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of exposure; with warm (30-40°C) water and blotted dry with absorbent paper
- Time after start of exposure: 24 hours
A Perspex `Elizabethan´ collar was then fitted to each animal for the remainder of the experimental day to minimize oral ingestion of residual test substance.
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

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:
. twice daily checked for mortalities
. on Day 1 after dosing and at frequent intervals checked for clinical signs, subsequent twice daily
- bodyweight: recorded on Day 1, 8 and 15, individual bodyweight chances were caluculated weekly.
-macroscopic examination: macroscoupc appearance of all examined tissues was recorded at the end of the experiment
- Dermal responses: Local dermal irritaion at the treatment site was assessed daily using the following numerical system:

No erythema 0
Slight erythrema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:

No oedema 0
slight oedema 1
Well-defined oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single dermal application of MCPP-P 2-EHE at 2000 mg/kg bw.

Clinical signs:

other: There were no clinical signs of reaction to treatment.

Gross pathology:

Terminal examination revealed white foci (up to 3 mm in diameter, extending into the parenchyma or seen on the cut surface of the tissue) on the liver capsular region of all rabbits.

Other findings:

Dermal responses:Slight erythema accompanied by slight edema was recorded at the sites of application of MCPP-P 2-EHE on Day 2. These reactions persisted throughout the first week of the study. Irritation had resolved for the majority of animals by Day 9 although reactions continued for one male until Day 12.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 for MCPP-P 2EHE is greater than 2000 mg/kg bw.

Executive summary:

A limit test to assess the acute dermal toxicity of MCPP-P 2-EHE on rabbit skin was performed according to EPA Pesticide Assessment Guidelines, 81-2 acute dermal toxicity (Revised Edition November 1984). The test item was applied undiluted on clipped skin of 5 male and 5 female rabbits at a dose level of 2000 mg/kg bw for an observation period of 14 days. There were no deaths and no clinical signs of reaction to treatment and normal body weight gain during the study. Slight erythema and edema was recorded at the sites of application on Day 2. Dermal irritation persisted throughout the first week of the study. Irritation had resolved by Day 8 or 9 for the majority of animals and Day 13 for one animal. Macroscopic examinations revealed white foci on the liver capsular region of all rabbits. The LD50 of MCPP-P 2-EHE was found to be greater than 2000 mg/kg bw.