[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-11-12 to 2007-11-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 24th April, 2022

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

2004

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

477-470-2

EC Name:

-

Molecular formula:

UVCB substance

IUPAC Name:

Reaction product of tetraethylsilicate, ethylpolysilicate, dioctyltinoxide, methanol and benzoic acid

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

New Zealand White Hsd If:NZW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: not specified
- Weight at study initiation: 2.1 - 3.4 kg
- Fasting period before study: overnight, after administration of the test item the food was withheld for for further 3- 4 h
- Housing: ABS-plastic rabbit cages, floor 4200 cm2
- Diet (ad libitum): Altromin 2123 maintanenance diet for rabbits, specific pathogen-free
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
- Microbiological status: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h after patch removal
120 h after patch removal if symptoms present after 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap: gauze patch, held in place with non-irritating tape and fixed with semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE: not specified. It was stated that the test item was stuck to the application site

OBSERVATION TIME POINTS: 1, 24, 38 nd 72 h

SCORING SYSTEM: according to Draize (1944)

1. Erythema and Eschar Formation

No erythema 0
Very slight erythema (barely perceptible) ..................................................................................1
Well defined erythema ................................................................................................................ 2
Moderate to severe erythema .................................................................................................... 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema ........ 4
Maximum possible: 4

2. Oedema Formation

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 120 h

Remarks on result:

probability of moderate irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Reversibility of any observed effect: changes fully reversible within 5 days

Other effects:

The test item showed slightly irritant, but no corrosive effects on the intact skin of 3 rabbits after a contact time of 4 h.

The scores for animals 1, 2 and 3 were (0.67, 1, 0.67) for erythema and (0, 0, 0) for edema.

Animals No. 1 and 3: All symptoms were fully reversible within 72 hours after removing the patch.

Animal No. 2: All syptoms were fully reversible within 120 hours after removing the patch.

There were no significant body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the reported data of this irritation study, it can be stated that the test item showed slightly irritant effects, which were fully reversible.

Executive summary:

The skin irritation potential of the test item was assayed in an in vivo skin irritation study according to OECD 404 in three New Zealand rabbits. 0.5 mL of the test item was applied per test side (dorsal area of the trunk), the untreated side served as control. The exposure period was 4 h. A semiocclusive dressing was used. The test sides were observed 1, 24, 48 and 72 h after patch removal for erythema and oedema.

The test item showed slightly irritant, but no corrosive effects on the intact skin of 3 rabbits after a contact time of 4 h. The scores for erythema and edema were (0.67, 0) for animal 1, (1, 0) for animal 2 and (0.67, 0) for animal 3.

Animals No. 1 and 3: All symptoms were fully reversible within 72 hours after removing the patch.

Animal No. 2: All symptoms were fully reversible within 120 hours after removing the patch.

There were no significant body weight changes during the contact and observation period.

The test item was concluded to be slightly irritant, with full reversibility.