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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
A dermal irritation/corrosion test in White New Zealand rabbits was performed according to the method described in OECD guideline 404.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (R)-2-Chlormandelsäure
- Physical state: Solid, crystalline 1 white to slight yellowish;
- Analytical purity: 99.7 area-%
- Lot/batch No.: TI 38-02-01
- Stability: The stability under storage conditions over the exposure period was guaranteed by the sponsor.
- Storage condition of test material: Room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.
- Other: pH-value of a 10% aqueous suspension: about 1.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 7 - 9 months
- Weight at study initiation: 3.55 kg - 3.86 kg
- Housing: Single housing
- Diet: Kliba-Labordiät, Provimi Kuba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened in water
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- semiocclusive dressing consisting of a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and FixomuII-stretch (adhesive fleece), Beiersdorf AG


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol/water (1:1)
- Time after start of exposure: 4 hours


SCORING SYSTEM: The Draize scoring system was used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1-3
Time point:
other: 24,48,72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
1-3
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Results summary

After the exposure period of 3 minutes, no skin findings were observed in all animals. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and edema.

 

After the exposure period of 1 hour slight to moderate erythema was observed in all animals during the course of the study. The cutaneous reactions were reversible in all animals within 7 days after removal of the patch. The average score (24 to 72 hours) for irritation was calculated to be 1.3 for erythema and 0.0 for edema.

 

After the exposure period of 4 hours slight to marked erythema was observed in all animals during the course of the study. The cutaneous reactions were reversible in all animals within 72 hours after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.8 for erythema and 0.0 for edema.

 

Considering the described cutaneous reactions as well as the average score for irritation, (R)-2-Chlormandelsäure does not show a skin irritation potential under the test conditions chosen.

Results details

 

ANALYSES

Food analyses:

In view of the aim and duration of the study the contaminants occurring in commercial food should not influence the results.

 

Drinking water analyses:

In view of the aim and duration of the study there are no special requirements exceeding the specification of drinking water.

 

CLINICAL EXAMINATIONS AND ASSESSMENT OF SKIN FINDINGS

After the exposure period of 3 minutes, no skin findings were noted in all animals. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and edema.

 

After the exposure period of 1 hour the following findings were observed:

Moderate erythema (grade 2) was observed in all animals 1 hour after removal of the patch and decreased in all animals to slight erythema (grade 1) 24, 48 or 72 hours after removal of the patch, respectively and persisted in all animals until 72 hours after removal of the patch.

 

No other cutaneous reactions were observed during the study. The cutaneous reactions were reversible in all animals within 7 days after removal of the patch.

 

Mean scores over 24, 48 and 72 hours for each animal were 1.3, 1.0 and 1.7 for erythema and 0.0 for edema.

 

After the exposure period of 4 hours the following findings were noted:

Marked erythema (grade 3) was observed in two animals and slight erythema (grade 1) in one animal 1 hour after removal of the patch. Marked erythema decreased in the two animals to moderate erythema (grade 2) after 24 hours and to slight erythema (grade 1) 48 hours after removal of the patch. Slight erythema persisted in the third animal until the24 hour reading.

The cutaneous reactions were reversible in one animal within 48 hours and in two animals within 72 hours after removal of the patch.

 

Mean scores over 24, 48 and 72 hours for each animal were 1.0, 1.0 and 0.3 for erythema and 0.0 for edema.

 

Readings

Animal

Exposure period: 3 min

Erythema

Edema

Additional findings

1 h

1

0

0

 

2

0

0

 

3

0

0

 

24 h

1

0

0

 

2

0

0

 

3

0

0

 

48 h

1

0

0

 

2

0

0

 

3

0

0

 

72 h

1

0

0

 

2

0

0

 

3

0

0

 

7 d

1

0

0

 

2

0

0

 

3

0

0

 

Mean

24, 48, 72 h

1

0

0

 

2

0

0

 

3

0

0

 

Mean 24, 48, 72 h

1-3

0

0

 

 

Readings

Animal

Exposure period: 1 h

Erythema

Edema

Additional findings

1 h

1

2

0

 

2

2

0

 

3

2

0

 

24 h

1

2

0

 

2

1

0

 

3

2

0

 

48 h

1

1

0

 

2

1

0

 

3

2

0

 

72 h

1

1

0

 

2

1

0

 

3

1

0

 

7 d

1

0

0

 

2

0

0

 

3

0

0

 

Mean

24, 48, 72 h

1

1.3

0

 

2

1.0

0

 

3

1.7

0

 

Mean 24, 48, 72 h

1-3

1.3

0

 

 

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

1 h

1

3

0

 

2

3

0

 

3

1

0

 

24 h

1

2

0

 

2

2

0

 

3

1

0

 

48 h

1

1

0

 

2

1

0

 

3

0

0

 

72 h

1

0

0

 

2

0

0

 

3

0

0

 

7 d

1

0

0

 

2

0

0

 

3

0

0

 

Mean

24, 48, 72 h

1

1

0

 

2

1

0

 

3

0.3

0

 

Mean 24, 48, 72 h

1-3

0.8

0

 

(Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983)

(Calculation of the mean according to 93/21/EEC criteria of April 27th, 1993)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating