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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 25, 1992 - September 1, 1992
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:
1002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
EPA FIFRA Subdivision F Guideline 81-5 Primary dermal irritation, revised Edition November 1984
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 10-14 weeks
- Weight at study initiation: 2.4 to 3.0 kg
- Housing:ndividually in plastic cages with perforated floors
- Diet: ad libitum, Standard laboratory diet SDS Stanrab
- Water: ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained at approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12/12






Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
single treatment
Observation period:
8 days
Number of animals:
six
Details on study design:
TEST SITE
- Area of exposure: dorsal area of 25mm2
- % coverage: 25 mm x 25 mm
- Type of wrap if used: gauze pad, covered with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water ( 30°- 40°C)
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- on Day 1 ( approximately 30 minutes after removal of the dressings)
- on Day 2, 3 and 4 (= 24h, 48h and 72h)
- additional observations were made on Days 5 to 8

SCORING SYSTEM:
- Method of calculation: Local dermal irritation was assessed using the prescribed numerical system:

Erythema and eschar formation:

No erythema 0
Very slight erythrema (barely perceptible) 1
well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:

No oedema 0
Very slight oedema (barely perceptible) 1
Slight 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

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Very slight erythrema was observed in a single animal only immediately after the removal of the dressings. By Day 2 very slight to well-defined erythema with or without very slight to slight edema was seen in all animals. Very slight erythema accompanied by very slight edema was observed in all animals on Day 3. All dermal reactions had resolved in three animals by Day 4 and in a further animal by Day 5. In the remaining two rabbits very slight dermal reactions persisted up to and including Day 7.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Table 1: Dermal reactions observed after application of MCPP-P 2-EHE

Rabbit number (# animal)

E = Erythema

O= Oedema

Day

 1*          2         3          4           5         6         7        8

1 (male)

E

O

 0           1         1           0          0          0        0         0

 0           1         1           0          0          0        0         0

 0           1         1           0          0          0        0         0

 0           0         1           0          0          0        0         0

 1           2         1           1          1          1        1         0

 0           1         1           1          1          1        1         0

 0           2         1           0          0          0        0         0

 0           1         1           0          0          0        0         0

 0           1         1           1          0          0        0         0

 0           2         1           0          0          0        0         0 

 0           1         1           1          1          1        1         0

 0           1         1           1          1          1        1         0

2 (male)

E

O

3 (male)

E

O

4 (male)

E

O

5 (male)

E

O

6 (male)

E

O

*Approximately 30 min after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
MCPP-P 2-EHE showed no skin irritation potential.
Executive summary:

A dermal skin irritation study to assess the skin irritation potential of MCPP-P 2-EHE was performed. The method followed was that described in EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic animals 81-5 Primary dermal irritation (Version 1984). Six rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for a maximum of eight days. A single semi-occlusive application of MCPP-P 2-EHE to intact skin for 4 hours elicited very slight to well-defined dermal reactions, while all reactions had resolved by day 8. The mean value for erythema was not higher than 1.3 and the mean value for edema was not higher then 1 (according Draize score).