Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and valid testing guidelines, therefore it is considered relevant, adequate and reliable for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Netzer SB 10, sulfobernsteinsäureester-Natriumsalz, Di-isodecylsulfobernsteinsäureester-mono-natriumsalz
- Physical state: Almost colorless, clear liquid
- Analytical purity: 63.0-67.0%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: E06 124 505 (produced 1985-07-03)
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: In the dark, at 22°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Age at study initiation: Ca. 3-5 months
- Weight at study initiation: 2.1-2.5 kg
- Fasting period before study: Not provided
- Housing: Individual cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät- Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum as well as hay (ca. 15 g täglich)
- Water (e.g. ad libitum): Deionized, chlorinated water from automatic drinkers, ad libitum
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Not provided
Observation period:
72 hours and after this period additional observations till 21 days for the positive findings
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: In the dorsal region of the trunk
- % coverage: Not provided
- Type of wrap if used: An adhesive patch (2.5 x 2.5 cm) with cellulose coating (Custom-made by Fa. Beiersdorf AG, Hamburg) was fixed to the prepared skin site. Under these patches 0.5 mL of the undiluted test substance was applied. Subsequently, the area was covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Erythema and eschar formation as well as edema formation were evaluated numerically. All other skin changes were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Irritant / corrosive response data:
One to 48 hours after removal of the patch, the animals showed barely perceptible to clearly defined erythema and partially very slight to slight edema .
72 hours after application partially clearly defined to moderate erythema and very slight edema were observed. In one animal the reddening was not assessable due to discoloration.
7 days after application no irritation was observed. 14 to 21 days after application, one animal showed barely perceptible to moderate erythema. The irritations 24 hours to 14 days after patch removal partially were dry, brittle, fine or large flaking and parchment-like skin surface, fissured skin, induration, eschar formation and large-area yellow or light-brown skin discoloration.

Any other information on results incl. tables

Table 2. Individual findings

Time after patch removal

1h

24h

48h

72h

7d

14d

21d

Animal No.

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

 

Erythema and eschar formation

2

1

1

2

2

1

2

2

2

3

*

2

0

0+

0+

0

3

0

0

1

0

Edema

2

1

1

0

2

2

0

2

2

0

1

1

0

0

0

0

0

0

0

0

0

 

Skin surface:

-dry, brittle

- scaly

-large scaly

-indurated

-parchment-like

 

 

 

 

 

 

 

x

 

 

x

 

 

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

x

 

 

x

x

x

 

x

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

x

x

 

x

x

 

 

 

Deeply fissured skin

 

 

 

 

 

 

 

 

 

x

 

 

 

 

 

 

 

 

 

 

 

Eschar formation

 

 

 

 

 

 

 

 

 

x

 

 

 

 

 

 

 

 

 

 

 

Skin discoloration

-large area yellow

-large area light-brown

 

 

 

 

 

x

 

 

x

x

 

x

x

 

 

 

x

 

 

x

 

 

 

 

 

 

* due to discoloration not assessable + judged for the discoloration

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on this study and taking into account any other skin changes, the test item is classified as irritant according to the classification criteria of Directive 83/467/EEC and the Hazardous Substances Regulation and is labeled R 38- irritating to the skin.
Executive summary:

Three New Zealand White rabbits were shaved in an area of ca. 25 cm2,dorsal of the trunk , approximately 24 hours before the start of the study. An adhesive patch (2.5 x 2.5 cm) with cellulose coating (Custom-made by Fa. Beiersdorf AG, Hamburg) was fixed to the prepared skin site. Under these patches 0.5 mL of the undiluted test item was applied. Subsequently, the area was covered with a semi-occlusive bandage.

Observations were performed 30-60 minutes and 24, 48 and 72 hours after removal of the patch. At 72 hours there were still findings , thus additional observations were done at 7, 14 and 21 days after patch removal.
Erythema , eschar formation and edema were numerically scored. Mean 24-72h scores were 2/4 for erythema and 1.1/4 for edema. All other skin changes were recorded.

One to 48 hours after removal of the patch, the animals showed barely perceptible to clearly defined erythema and partially very slight to slight edema . 72 hours after application partially clearly defined to moderate erythema and very slight edema were observed. In one animal the reddening was not assessable due to discoloration. 7 days after application no irritation was observed. 14 to 21 days after application, one animal showed barely perceptible to moderate erythema. The irritations 24 hours to 14 days after patch removal partially were dry, brittle, fine or large flaking and parchment-like skin surface, fissured skin, induration, eschar formation and large-area yellow or light-brown skin discoloration.
Based on this study and taking into account any other skin changes the test item is classified as irritant according to the classification criteria of Directive 83/467/EEC and the Hazardous Substances Regulation and is labeled R 38- irritating to the skin.