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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
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted under GLP application, and it was done according to valid methods. Therefore it is considered relevant, reliable and adequate for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Chloracetamid; Diamoll C
- Physical state: White crystalline powder
- Analytical purity: 99.5%
- Composition of test material, percentage of components: See confidential details
- Purity test date: 1993-04-05
- Lot/batch No.: 676
- Expiration date of the lot/batch: August 1993
- Stability under test conditions: Under storage conditions stability guaranteed until August 1993
- Storage condition of test material: In the dark at room temperature in a fume cupboard

Test animals

Species:
rabbit
Strain:
other: Albino New Zealand White Chbb: NZW (SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. Karl Thomae GmbH, Biberach (Germany), SPF-breeding
- Age at study initiation: Ca. 3 - 5 months
- Weight at study initiation: 2,5 - 2,8 kg
- Housing: Individual cages (battery cages)
- Diet: Altromin 2123 Haltungsdiät – Kaninchen by Altromin-GmbH, Lage/Lippe (Germany), ad libitum; also hay, ca. 15 g daily
- Water: Deionised chlorinated water, automatic watering, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18± 3 °C
- Humidity (%):55 ± 20%
- Air changes (per hr): Fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1993-07-06 To: 1993-07-13

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg chloroacetamide
- Concentration (if solution): moistened with 0.25 mL 0.9% NaCl solution

Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: The mixed substance was applied on a wound plaster with 2.5 X 2.5 cm cellulose pad and the plaster strips were attached to the prepared skin site under a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
See "Any other information on material and methods incl. tables"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema and eschar formation
Basis:
mean
Time point:
other: mean; ,24, 48, 72 h after removal of plaster
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: erythema and eschar formation
Basis:
animal #1
Time point:
other: mean; 24, 48, 72 h after removal of plaster
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7days
Irritation parameter:
other: erythema and eschar formation
Basis:
animal #2
Time point:
other: mean; 24, 48, 72 h after removal of plaster
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: erythema and eschar formation
Basis:
animal #3
Time point:
other: mean; 24, 48, 72 h after removal of plaster
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean; 24, 48, 72 h after removal of plaster
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean; 24, 48, 72 h after removal of plaster
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean; 24, 48, 72 h after removal of plaster
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean; 24, 48, 72 h after removal of plaster
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The animals showed 1hour until 3 days after application very slight erythema to moderate to severe erythema, as well as very slight to moderate edema. Additional in one animal the skin was dry, rough and with coarse scales.

Any other information on results incl. tables

Table 1. Results

Sex: Female

Animal Number

Erythema (time after decontamination)

Mean score*

30-60 min

1 day

2 days

3 days

7 days

96

2

2

1

0

0

1.0

97

2

1

0

0

0

0.3

98

3

2

2

2

0

2.0

 OVERALL MEAN ERYTHEMA (24, 48, 72h): 1.1

Animal Number

Edema (time after decontamination)

Mean score*

30-60 min

1 day

2 days

3 days

7 days

96

2

1

0

0

0

0.3

97

1

0

0

0

0

0.0

98

3

2

1

1

0

1.3

OVERALL MEAN EDEMA (24, 48. 72h): 0.5

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Skin irritation test in rabbits has shown that Chloroacetamide according to the present study is assessed as slightly irritating.
Executive summary:

A dorsal area of the trunk of approximately 25 cm2 of 3 rabbits was shaved ca. 24 hours before the start of the test . Each animal (intact skin) was applied with 500 mg Chloroacetamide (made into a paste with 0.25 mL of 0.9% NaCl solution). The mixed substance was applied on a wound plaster with 2.5 X 2.5 cm cellulose pad and the plaster strips were attached to the prepared skin site under a semiocclusive bandage. After 4 hours exposure, the remaining test substance was washed carefully with lukewarm tap water. Observations were done at 30-60 minutes and at 24, 48 and 72 hours after removal of the plaster. As there were some other findings in 1 animal (skin suface: coarse scales, dry, rough), additional observation was done up to 7 days. All changes were reversible within 7 days. Althoug Chloroacetamide was assessed as slightly irritating, there is no reason for classifcation.

The Skin irritation test in rabbits has shown that Chloroacetamide according to the present study is assessed as slightly irritating.