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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:
Dec 2019 - Feb 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 28, 2015
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Landesanstalt für Umwelt Baden-Württemberg

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
100 g/100 g (UVCB substance)


Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
-Test item No.: 12/0227-2
- Batch No.of test material: 0016046440
- Expiration date of the lot/batch: January 07, 2020
- Purity: 100 g / 100 g (UVCB substance)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; avoid temperature < 10°C
- The stability of the test item under storage conditions over the test period was guaranteed by the sponsor
- Solubility and stability of the test substance in the solvent/vehicle: The test item was homogeneous by visual inspection

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Undiluted applicaton

OTHER SPECIFICS:
- Density [g/mL]: 0.960 (dertermined by testing facility)
- Physical state/ color: Liquid, viscous / yellowish to pink, clear
- pH-value: Approx. 5.5 (undiluted test item, determined by testing facility)

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL(NZW) – (SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Approx. 6 months
- Weight at study initiation: 4.03 kg – 4.44 kg
- Sex: Males
- Housing: Single housing in stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm². The animals were housed in fully air-conditioned rooms
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: At least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test substance
Duration of treatment / exposure:
Exposure for 4 hours
Observation period:
up to day 21
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol® and Lutrol®/water (1 : 1).
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
- Readings at 24, 48 and 72 h

SCORING SYSTEM:
According to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 1.3 for erythema and 0.0, 0.0 and 0.0 for edema, respectively.
The cutaneous reactions were reversible in one animal within 24 hours, in a second animal within 14 days after removal of the patch.
In one animal, the cutaneous reactions were not reversible within 21 days. In this animal, very slight erythema (grade 1) and yellowish discoloration were seen on study day 21.

Other effects:
yellowish discoloration of the application area in some animals

Any other information on results incl. tables

Tab.1: Tabulation of irritant response, data for each individual animal at each observation time as well as calculation of the means

Readings

Animal No.

Erythema

Edema

Additional Findings

0h

1

1

0

 

2

1

0

 

3

1

0

 

1h

1

1

0

 

2

2

0

 

3

2

0

 

24h

1

0

0

 

2

2

0

 

3

2

0

 

48h

1

0

0

yellowish discoloration of the application area

2

2

0

-

3

1

0

-

72h

1

0

0

yellowish discoloration of the application area; SD

2

2

0

yellowish discoloration of the application area

3

1

0

yellowish discoloration of the application area

7d

1

-

-

 

2

2

0

yellowish discoloration of the application area

3

1

0

yellowish discoloration of the application area

14d

1

-

-

-

2

0

0

yellowish discoloration of the application area; SD

3

1

0

yellowish discoloration of the application area

21d

1

-

-

-

2

-

-

-

3

1

0

yellowish discoloration of the application area

Mean

24h – 72h

1

0.0

0.0

 

2

2.0

0.0

 

3

1.3

0.0

 

Mean

-

1.1

0.0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not show a skin irritating potential under the test conditions chosen.
Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 mL of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal, supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and at weekly intervals until day 21 at the latest.

The following test item-related clinical observations were recorded during the course of the study:

- Very slight to well-defined erythema (grade 1 to 2)

- Yellowish discoloration of the applications area

The cutaneous reactions were reversible in one animal within 24 hours and in a second animal within 14 days after removal of the patch. In one animal, cutaneous reactions were not reversible within 21 days. In this animal, very slight erythema (grade 1) and yellowish discoloration were seen on study day 21.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 1.3 for erythema and 0.0, 0.0 and 0.0 for edema, respectively.

Considering the described cutaneous reactions as well as the average score for irritation of the test item, it does not show a skin irritating potential under the test conditions chosen.