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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:
from 1994-10-18 to 1994-12-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study performed under GLP without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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 animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97633 Sulzfeld.
- Age at study initiation: not reported
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: individual caging in metal wire cages
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum
- Water (e.g. ad libitum): tap water from an automatic watering system, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5
- Humidity (%): 50 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 1994-10-18

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Hair was clipped on the dorsal area of the trunk one day before the application
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:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal. Additional examinations 6, 8 and 10 days after patch removal.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: median on the dorsal thoracal region
- % coverage: test substance spread over an area of approximately 6 cm2
- Type of wrap if used: plastic collar

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off using wet cellulose tissue
- Time after start of exposure: 4 hours

SCORING SYSTEM:
ERYTHEMA/ESCHAR FORMATION
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) or eschar formation (injuries in depth)

OEDEMA FORMATION
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well defined by definite raising)
3: Moderate oedema (raised approximately 1 mm)
4: Severe oedema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of scores at 24, 48 and 72 hours
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of scores at 24, 48 and 72 hours
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of scores at 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of scores at 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of scores at 24, 48 and 72 hours
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of scores at 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 10 days
Other effects:
Animal 1: Eschar formation after 72 hours. Eschar almost completely desquamated after 6 days and completely desquamated after 8 days, with intact skin below.
Animal 2: No additional observations.
Animal 3: Eschar on four sites, diameter approximately 1 mm each from 48 hours to 8 days. On day 8, eschar completely desquamated, intact skin below.

Any other information on results incl. tables

Scores of the application sites

Time after the end of exposure

Erythema / Eschar formation

Oedema formation

Animal No

1041

1042

1043

1041

1042

1043

1 h

2

2

2

3

3

3

24 h

2

2

3

3

2

4

48 h

4

2

4

4

2

4

72h

4

2

4

4

2

4

mean(24-72h)

3.3

2.0

3.7

3.7

2.0

4.0

6 d

2

1

4

2

1

4

8 d

0

0

1

0

0

2

10 d

 

 

0

 

 

0

Applicant's summary and conclusion

Interpretation of results:
other: EU CLP criteria
Remarks:
Skin irritating (Category 2)
Conclusions:
The substance is irritating to the skin.
Executive summary:

The potential of the substance to induce skin irritation was investigated in a GLP study in conformance with OECD TG 404.

0.5 mL test substance was applied to the intact skin of 3 rabbits in a semi-occlusive application. After 4 hours, residual test substance was wiped off. Animals were examined for erythema/eschar and oedema as well as for other local and systemic signs approximately 1, 24, 48 and 72 hours after patch removal. Additional examinations were performed 6, 8 and 10 days after patch removal. The mean of the erythema/eschar scores at 24, 48 and 72 hours was 3.3, 2.0 and 3.7 in animal 1, 2 and 3, respectively.

The mean of the oedema scores at 24, 48 and 72 hours was 3.7, 2.0 and 4.0. Scores returned to "0", i. e. normal, within 8 days after patch removal in 2/3 animals respectively within 10 days after the end of exposure in the third animal.

In conclusion, the substance has to be regarded as irritating to the skin.