[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:

December 13, 2018 to April 25, 2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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: GB/T 21604-2008 Chemicals-Test method of acute dermal irritation/corrosion

GLP compliance:

no

Remarks:

According GLP but not certified

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts

Cas Number:

2210238-42-7

IUPAC Name:

Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts

Test material form:

solid

Remarks:

This solid sample was obtained from the original liquid form by removing water.

Details on test material:

CAS number: 2210238-42-7

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:

not specified

Details on test animals or test system and environmental conditions:

4 male healthy and adult rabbits with 2.3 - 2.5 kg body weight which purchased from TianQin biotechnology Ltd., Changsha. The number of the manufacturing license: SCXK(Xiang) 2014-0010. On arrival, the animals were acclimated to the laboratory accommodation 5 days before commencement of the exposure.

Common nutrient feed were supplied by TianQin Biotechnology Ltd., Changsha. The number of the manufacturing license: SCXK(Xiang)2014-0011.

The animals were housed in common environment. The temperature of the experimental animal room was 21 - 23°C and the relative humidity was 44 - 60 percent. The used license NO. of the experimental animal: SYXK(Xiang) 2017-0001.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

About 0.5 g test substance, wetted with pure water, was applied uniformly to a small area of skins on the left sides of the animals. The area for applying the test substance should be smaller than which was prepared.

Duration of treatment / exposure:

4 hours

Observation period:

24, 48, 72 hours to the 12th day after patch removal.

Number of animals:

4

Details on study design:

Approximately 24 h before the test, about 3 cm x 3 cm areas of fur was removed from both left and right sides of the animals dorsal. Only the animals with healthy intact skins were used.

About 0.5 g test substance, wetted with pure water, was applied uniformly to a small area of skins on the left sides of the animals. The area for applying the test substance should be smaller than which was prepared. The test substance was covered with a gauze patch, which was fixed with nonirritating tapes throughout the 4 h exposure period. At the end of the exposure period, the residual test substance was removed with water.

The signs of skin irritation at application site were observed at 24, 48, 72 h to the 12th day after patch removal. The scores were recorded. Adjacent areas of untreated skins of each rabbit served as control for the test.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 12 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 9 days

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4 days

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Mild erythema and edema for 3 animals were observed at 24 h after the residual test substance removed, purple-red erythema and eschar were observed in one of these three animals at 48 h, and recovered at the 12th day, the skin irritations of other 2 animals alleviated and recovered during 72 h to the 4th day. No skin irritation was observed in the other animal during the observation period.
The result and contents were showed in table 2.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result, registration substance do not met the GHS criteria.

Executive summary:

The body weights of animals increased at the end of the test.

Mild erythema and edema for 3 animals were observed at 24 h after the residual test substance removed, purple-red erythema and eschar  were observed in one of these three animals at 48h, and recovered at the 12th day, the skin irritations of other 2 animals alleviated and recovered during 72h to the 4th day. No skin irritation was observed in the other animal during the observation period.