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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. 38, No. 187, Section 1500.41, P.27019
Version / remarks:
Sept. 27, 1973
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Mecoprop
EC Number:
230-386-8
EC Name:
Mecoprop
Cas Number:
7085-19-0
Molecular formula:
C10H11ClO3
IUPAC Name:
2-(4-chloro-2-methylphenoxy)propanoic acid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Males: 2.97 kg, females: 3.13 kg (mean weights)
- Housing: Cages were made of stainless steel with wire mesh walk floors. Floor area: 40 cm x 51 cm. Animals were housed 1 per cage. No bedding in the cages; sawdust in the waste trays.
- Diet: About 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study in the animal care unit; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark (06.00 - 18.00 hours/ 18.00 - 06.00 hours)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped (intact and abraded)
Vehicle:
water
Remarks:
Distilled water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: Around 0.5 g of test material.

NEGATIVE CONTROL
- Amount(s) applied: Untreated skin sites of the same animals were used as negative controls.
Duration of treatment / exposure:
24 hours
Observation period:
15 days
Number of animals:
2 males and 4 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm on intact and abraded skin. Fur was clipped at least 15 hours before the application of the test material.
- The test patch (2.5 x 2.5 cm) was covered with about a 0.5 mm layer of the 50 % suspension (about 0.5 g of test material).
- Application site: Upper third of the back or flanks.

REMOVAL OF TEST SUBSTANCE
- Test material is wiped off after 24 hours.

OBSERVATION TIME POINTS
- 30 to 60 minutes after removal of the test patches and 48 h, 72 h, 8 d and 15 d after the beginning of the test material application.

SCORING SYSTEM:
- Draize method.

ADDITIONAL EXAMINATIONS
- After sacrifice the animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross pathological examination after incision of the skin. If there are differences between clinical and pathological findings, only the latter are included in the final report.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: abraded skin

Any other information on results incl. tables

Summary of Results

Readings

Animal

Intact Skin

Abraded Skin

Individual Irritation Index

Erythema (E)

Oedema (ED)

Symtpoms

Erythema (E)

Oedema (ED)

Symtpoms

24 hours

1

2

2

-

2

2

HE

4.0

2

2

2

-

2

3

HE

4.5

3

2

3

-

2

3

-

5.0

4

2

1

-

2

1

-

3.0

5

2

1

-

2

1

-

3.0

6

2

1

-

2

2

-

3.5

Mean

2.0

1.7

 

2.0

2.0

 

3.8

48 hours

1

2

1

HE

2

2

HE

3.5

2

2

1

HE

2

2

HE

3.5

3

2

1

-

2

2

 

3.5

4

2

1

-

2

1

 

3.0

5

2

1

-

2

1

 

3.0

6

2

1

-

2

2

 

3.5

Mean

2.0

1.0

 

2.0

1.7

 

3.3

72 hours

1

2

1

HE

2

2

HE

3.5

2

2

1

-

2

2

HE

3.5

3

2

1

-

2

2

 

3.5

4

2

1

-

2

1

 

3.0

5

2

0

-

2

1

 

2.5

6

2

1

-

2

2

HE

3.5

Mean

2.0

0.8

 

2.0

1.7

 

3.3

8 days

1

1

0

S

1

0

S

1.0

2

0

0

S

1

0

S

0.5

3

*

*

S2

*

*

S2

-

4

1

0

S

1

0

S

1.0

5

0

0

S

1

0

S

0.5

6

0

0

-

1

0

S

0.5

Mean

0.3

0

 

1.0

0

 

0.7

15 days

1

0

0

S

0

0

S

0

2

0

0

S

0

0

S

0

3

*

*

S2

*

*

S2

-

4

0

0

S

0

0

S

0

5

0

0

S

0

0

S

0

6

0

0

S

0

0

S

0

Mean

0

0

 

0

0

 

0

Primary irritation index =42.5/12 = 3.5

S2 = Death not due to test material

HE = Haemorrhagic

S = Scaling

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of this study, the test material was not classified in accordance with EU criteria.
Executive summary:

The potential of the test material to cause irritation to the skin of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.41, P.27019, a study similar in design to OECD 404.

Six Vienna white rabbits (two males and four females) were treated with a 50 % w/w aqueous formulation of the test material for 24 hours under an occlusive dressing. The test sites were observed for 15 days following application and assessed using the Draize scale.

Under the conditions of this study, the test material was not classified in accordance with EU criteria.