[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 30, 2018 to April 15, 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 21603-2008 Chemicals-Test method of acute oral toxicity

Version / remarks:

GB/T 21603-2008 Chemicals-Test method of acute oral toxicity

GLP compliance:

no

Remarks:

According GLP but not certified

Test type:

standard acute method

Limit test:

no

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:

cream / paste

Remarks:

Pale yellow paste under 50℃. This sample was obtained from the original liquid form by removing water.

Details on test material:

pH: 9.0-10.5 (diluted 10% act. solution)
Stability: Stable in container after opening. Stable in water and in light. Stability in soil is
not applicable

Specific details on test material used for the study:

Expiry date: June 30, 2020
Storage Condition: Store container tightly closed in well-ventilated place. Store in corrosive resistant/container with a resistant in liner. Store locked up. Don ' t store with acids.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

20 female and 20 male SPF healthy adult Sprangue-Dawley rats with body weight of 193 - 252 g which purchased from the Slac JingDa Laboratory Animal Co., Ltd, Hunan Province. On arrival, the animals were acclimated to the laboratory accommodation for 3 days before exposure. The manufacturing license No. is SCXK(Xiang)2016-0002.


All of the cleaning feeds were supplied by Beijing Keao Xieli Feed Co., Ltd. The number of the production license: SCXK(Jing) 2014-0010.


Animals were housed in SPF barrier environment under the conditions of 60-68% relative humidity and 20-22°C. The utilization license No. of the experimental animal is SYXK (Xiang) 2017-0001.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

According to the result of preliminary test, four dose groups were used. Food but not water was withheld overnight to rats. The dosing liquids were administered orally to rats by gavage for 1.0 mL/100 g BW.

Doses:

The dose levels were 215 mg/kg, 464 mg/kg, 1000 mg/kg and 2150 mg/kg for C16K.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Mortality and clinical/behavioral signs of toxicity were recorded daily thereafter for 14 days.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 260 mg/kg bw

Based on:

act. ingr.

95% CL:

926 - 1 710

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 260 mg/kg bw

Based on:

act. ingr.

95% CL:

926 - 1 710

Mortality:

The details were showed in table 1 of attachment.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

Individual body weights increased at the 7th and 14th day after dosing were showed in table 2 of attachment.

Gross pathology:

No abnormal necropsy findings occurred in each dead animal.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 of Sulfonic acids, C16-sec-alkane hydroxy and C16-sec-alkene, potassium salts for male and female rats were 1260 mg/kg bw.

Executive summary:

The animals in the high dose group were lack of movement and dribbling in the time of 50 minutes after administration. The animals in the high dose group and second high dose group were lack of movement, back of a bow, dribbling and perineum filthiness in the time of 5 hours after administration. Some of the animals in these two dose groups died during the time of 5 ~ 23 h and the survival animals recovered in the time of 30 h after administration. No detectable clinical signs and no death occurred during the 14 days in the low and medium dose groups. The acute oral LD50 of the C16K for male and  female rats were 1260 mg/kg. Individual body weights increased at the 7th and 14th day after dosing. No abnormal necropsy findings occurred in each dead animal.