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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:
10.10.2006 - 24.10.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

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
impurity 1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three white rabbits of New Zealand strain were used in studies.
The rabbits were quarantined for at least 5 days and observed carefully during this time. The used rabbits were: one male 10 months old and two females 9.5 months old weighing on average 3.3 kg.

The day before the start of the experiment animals were shaved with electric razor on back and sides on appropriately big surface. Only those animals that showed no damages and no congestion of skin were used for the experiments.

Test system

Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The powdered test material was given in amount of 0.5 g to multilayered gauze patch with dimensions of 2.5 x 2.5 cm, moistured and then laid on the prepared skin of one rabbit (rabbit No 1). The surface of skin treated with the test material was about 6 cm2. The gauze patches were covered with PCV foil and fixed with sticking plaster. The rabbit back was covered with lignin and elastic bandage was used to make circular protecting band. After 4 hours exposure time the band and gauze patches were taken off and the test material was removed with help of water.
Following evaluation of the exposed skin and to confirm the obtained results the test material was administered to skin of the next two rabbits (rabbit No 2 and No 3) for four hours. The procedure was the same as in case of rabbit No 1.
Duration of treatment / exposure:
4 hours
Observation period:
Observations of skin were performed after 1, 24, 48 and 72 hours as well as 7 and 14 days since the end of exposure.
Number of animals:
3

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:
2
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Score:
1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
14 d
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
During observation after one hour since the end of exposure on skin in place of exposure all rabbits showed well defined erythema and additionally in rabbits Nos. 1 and 2 very weak (barely visible) edema was noticed. During observation after 24 hours since the end of exposure on skin in place of exposure rabbits Nos. 1 and 2 showed changes similar to those observed after 1 hour since the end of exposure. Rabbit no 3 showed very weak (barely visible) erythema.

During observation after 48 hours since the end of exposure, on skin in place of the exposure well defined erythema was observed in rabbits Nos. 1 and 2. No edema was noticed. Rabbit No 3 still showed very weak (barely visible) erythema.

During observation after 72 hours since the end of exposure rabbits Nos. 1 and 3 showed similar changes on skin in place of exposure as during observation after 48 hours. In rabbit No 2 erythema diminished to very weak (barely visible).

During observation after 7 days since the end of exposure rabbit No 1 showed very weak (barely visible) erythema and dried epidermis. Rabbits Nos. 2 and 3 did not show pathological changes.

During observation after 14 days since the end of exposure rabbit No 1 did not show any pathological changes.

Applicant's summary and conclusion

Conclusions:
Taking into account the obtained results, it can be stated that MCPP TECHNICAL does not irritate skin of rabbits.
Substance classified according to Harmonized Classification and Labeling provided in Annex VI of CLP Regulation.