[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:

January 15, 2019 to April 28, 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

Guideline:

other: State Ministry of Environmental Protection of the people's Republic of China, The Guidelines for the Testing of Chemicals (HJ/T 153-2004)-404.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic Acids, C18-alkane hydroxyl and C18-alkene, potassium salts

Cas Number:

2210238-56-3

IUPAC Name:

Sulfonic Acids, C18-alkane hydroxyl and C18-alkene, potassium salts

Test material form:

solid

Remarks:

Color: White to pale yellow This sample was obtained from the original liquid form by removing water.

Specific details on test material used for the study:

-Storage conditions
Store container tightly closed in well-ventilated place. Store in corrosive resistant container with a resistant inliner. Store locked up. Don't store with acids.

-Test item stability under storage conditions
Stable in container after opening. Stable in water and in light. Stability in soil is not applicable.

Test animals

Species:

rabbit

Strain:

other: Japanese white large-eared rabbits

Details on test animals or test system and environmental conditions:

Sex: Female, nulliparous and non-pregnant
Age: 84 - 140 d (at receipt)
Body Weight Range: 1.90 - 2.00 kg (at receipt)
Acclimatization: The animal was introduced for health examination within 24 hours, and the auricle number and cage card were used for unique identification within 24 hours, and the animal was weighed. After the introduction of single cage feeding, the animals were transferred from the stock animals to the experiment for 32 d of adaptation time, and the animals were observed every day during the adaptation period.


Husbandry: Animals are housed in building C room C127 at the start of study. Animals are individually raised in suspended, stainless wire cages (L38 cm x W50 cm x H35 cm) on cage racks (L200 cm x W65 cm x H 170 cm) during the acclimation and observation period. Animal use license No.: SYXK (Liao) 2015-0006.
Conditions: The ranges for room temperature and relative humidity are 18.04 - 23.00℃ and 40.28 - 67.40%, respectively. The animals are provided with a light cycle of 12 h light and 12 h dark.
Diet and Water: Animals are provided with pellet breeding rabbit diet by Liaoning Changsheng Biotechnology Co., Ltd. (Lot number 18112751, 19022261), License number: SCXK(Liao) 2015-0003. All the nutrition components and contaminants are within the permitted limits described in the national standard (GB 14924.3-2010 and GB/T 14924-2-2001 ). Results of diet analyses are supplied by the supplier.
Drinking water are provided ad libitum, which is analyzed once at least annually. All parameters are within the permitted limits described in the national drinking water standard (GB 5749-2006).
The diet and water are considered not to contain any contaminants that could affect the purpose or integrity of the study. Animals eat and drink freely during the experiment.


Animal use comply with national animal welfare laws and regulations (instructive notions with respect to caring for laboratory animals) (2006, PRC Ministry of Science). The animal care and use activities required for conduct of this study are reviewed and approved by the test facility Animal Care and Use Committee (IACUC). All survival animals were euthanized under CO2 after completing test and their corpse treatment were delivered to entrusted specialized agencies.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

The sample 0.5 g was evenly distributed on the gauze block attached to the small piece of medical non-irritant adhesive cloth (about 2. 5 cm x 2. 5 cm). Wetting with a small amount of purified water, and stick the drug-carrying white medical tape to the right-side hairless skin.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours to the 14th day after patch removal.

Number of animals:

3

Details on study design:

Approximately 24 hours before the test, the back and flanks of each animal was clipped free of fur. Care was taken to avoid abrading the skin, and only animals with healthy, intact skin by gross observation were used for the study. Cleared area was approximately 6 cm2. Two sites (2.5 cm x 2.5 cm) below the suprascapular area, on each side of the mid-line were selected as application sites. One site was designated as the test substance application site. The other site was served as a control site.


The sample 0.5 g was evenly distributed on the gauze block attached to the small piece of medical non-irritant adhesive cloth (about 2.5 cm x 2.5 cm). Wetting with a small amount of purified water, and stick the drug-carrying white medical tape to the right-side hairless skin. Then fixed with non-irritating rubber cloth. The other side of the skin served as a control. The application time was 4 hours. Then the skin of the tested area was cleaned with clear water.


Clinical Signs: All animals were observed once daily throughout the study.
Skin Reactions: Dermal observations for erythema, eschar and edema formation were conducted and recorded at immediately, 1, 24, 48, 72 h, 4-14 d after patch removal of the test item. In addition to the observation of irritation, all local toxic effects of skin and any systemic adverse effects were fully described and recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

not fully reversible within: 14 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 13 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

not fully reversible within: 14 d

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 11 d

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 9 d

Irritant / corrosive response data:

For No. 2100 animal the score of erythema and scab were 2, edema score was 1 one hour after removal of application. 24 hours after the application was removed, the score of erythema and scab were 2 and edema score was 2. 48 hours after the application was removed, the erythema and scorch score were 3, edema score was 2, and continued to the 5th day. On the 6th day, the scores of erythema and scab were 2, edema score was 2. On the 7th day, erythema and scab score were I, edema score was I, and continued to the 10th day. On the 11th day, erythema and scab score were 1, edema score was 0, and continued to the 14th day. For No. 2101 animal the score of erythema and scab were 2, edema score was 1 one hour after removal of application, and continued to 24 hours after the application was removed; 48 hours after the application was removed, the score of erythema and scab was 3 and edema score was 1 and continued to 72 hours after the application was removed; On the 4th day, the score of erythema and scab were 2 and edema was 1. On the 5th day, erythema and scab score were 1, edema score was 1, and continued to the 8th day. On the 9th day, erythema and scab score were 1, edema score was 0, and continued to the 12th day. On the 13th day, erythema and scab score was 0, edema score was 0, and continued to the 14th day.
For No. 2102 animal the score of erythema and scab were 2, edema score was 1 one hour after removal of application, and continued to 48 hours after the application was removed; 72 hours after the application was removed, the score of erythema and scab were 3 and edema was 2. On the 4th day, the score of erythema and scab were 2 and edema was 2. On the 5th day, erythema and scab score were 1, edema score was 1, and continued to the 8th day. On the 9th day, erythema and scab score were 1 and edema score was 0, and continued to the 14th day.
For the 3 animals, the skin erythema/eschar and edema mean scores after removal of the application for 24 h, 48 h, 72 h were respectively 2.7/2.0, 2.7/1.0, 2.3/1.3.
The average score of individual skin reaction in animals is shown in Table 2 and Table 3 of attachments.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

For the 3 animals, the skin erythema/edema and edema scores of the animals after removal of the application for 24 h, 48 h, 72 h were respectively 2.7/2.0, 2.7/1.0, 2.3/1.3. According to the GHS criteria for skin irritation/corrosivity, the sample is skin irritation: category 2

Executive summary:

Introduction

In accordance with the requirements of "chemical testing guidelines" (HJ/T 153-2004)-404 issued by the ministry of environmental protection of China, Japanese white large-eared rabbits were used as test animals to conduct acute skinirritation/corrosion tests in rabbits with C18K.

 

Method

Three rabbits were used for the experiment. 0.5 g of the skin of the right back of each animal was used as the test product, and the skin of the left back was used as the control. The exposure time was 4 hours. The infected skin was examined immediately after removal of the application at 1 h, 24 h, 48 h, 72 h, 4 -14 d.

 

Results

No. 2100 animal showed erythema immediately after the application was removed; Erythema and edema were observed 1 h after the application was removed and continued until 72 h after the application was removed. Erythema, edema and hyperkeratosis were observed on the 4th day and continued to the 10th day. Erythema and hyperkeratosis were observed on the 11th day and continued to the 14th day.

No. 2101 animal showed erythema immediately after the application was removed; Erythema and edema were observed 1 hour after removal of the application and continued to the 4th day. Erythema, edema and hyperkeratosis were observed on the 5th day and continued to the 8th day. Erythema and hyperkeratosis were observed on the 9th day and continued to the 12th day. Hyperkeratosis was observed on the 13th day and continued to the 14th day.

No. 2102 animal showed erythema immediately after the application was removed; Erythema and edema were observed 1 hour after removal of the application and continued to the 4th day. Erythema, edema and hyperkeratosis were observed on the 5th day and continued to the 8th day. Erythema and hyperkeratosis were observed on the 9th day and continued to the 14 day. For the 3 animals, the skin erythema/eschar and edema mean scores after removal of the application for 24 h, 48 h, 72 h were respectively 2.7/2.0, 2.7/1.0, 2.3/1 .3.

All animals showed expected gain in body weight during the course of study.

 

Conclusion

For the 3 animals, the skin erythema/edema and edema scores of the animals after removal of the application for 24 h, 48 h, 72 h were respectively 2.7/2.0, 2.7/1.0, 2.3/1.3. According to the GHS criteria for skinirritation/corrosivity, the sample is skin irritation: category 2.