Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from J-CHECK

Data source

Reference

Reference Type:

other: Authoritative database

Title:

Single Dose Oral Toxicity study of Sodium 1-methoxycarbonylpentadecane-2-sulfonate in rats

Author:

J-CHECK

Year:

2010

Bibliographic source:

Ministry of Health, Labour and Welfare", "Ministry of the Environment" and "National Institute of Technology and Evaluation, J-CHECK, 2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute Oral Toxicity study of Sodium 1-methoxycarbonylpentadecane-2-sulfonate in rats.

GLP compliance:

not specified

Test type:

other: Single Dose Oral Toxicity study

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

sodium 1-methoxy-1-oxohexadecane-2-sulfonate

Cas Number:

4016-24-4

Molecular formula:

C17H34O5SNa

IUPAC Name:

sodium 1-methoxy-1-oxohexadecane-2-sulfonate

Details on test material:

- Name of test material (as cited in study report): Sodium 1-methoxycarbonylpentadecane-2-sulfonate
- Molecular formula (if other than submission substance): C17H33NaO5S
- Molecular weight (if other than submission substance): 372.50 g/mole
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report): Sodium 1-methoxycarbonylpentadecane-2-sulfonate
- Molecular formula (if other than submission substance): C17H33NaO5S
- Molecular weight (if other than submission substance): 372.50 g/mole
- Substance type: Organic

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Remarks:

IGS

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0, 786, 983, 1229, 1536, 1920, 2400 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: Olive oil

Doses:

0, 786, 983, 1229, 1536, 1920, 2400 mg/kg

No. of animals per sex per dose:

Total: 70
0 mg/kg: 5 male, 5 female
786 mg/kg: 5 male, 5 female
983 mg/kg: 5 male, 5 female
1229 mg/kg: 5 male, 5 female
1536 mg/kg: 5 male, 5 female
1920 mg/kg: 5 male, 5 female
2400 mg/kg: 5 male, 5 female

Control animals:

yes

Details on study design:

- Duration of observation period following administration: No data available
- Frequency of observations and weighing: Yes
- Necropsy of survivors performed: yes
- Other examinations performed: Survival, clinical signs, body weight and gross pathology were examined.

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 142 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality observed

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 819

Based on:

test mat.

Remarks on result:

other: 50% mortality observed

Mortality:

n male, when treated with 983, 1229, 1536, 1920, 2400 mg/kg, Deaths was observed 6 to 24 hours after administration.

In female, 1536, 1920, 2400 mg/kg, Deaths was observed 6 to 24 hours after administration.

Clinical signs:

other: Decreased locomotor activity, ptosis, diarrhea, soiling of the perineal region and piloerection were observed in treated groups. Most clinical signs in the survivors showed a tendency for recovery on the day following administration and all had disappeare

Gross pathology:

Distention of the stomach with a watery content was observed in most of the animals which died

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

LD50 was considered to be to 2142 mg/kg bw for male and 1819 mg/kg bw for female when Crj:CD(SD)IGS male and female rats were treated Sodium 1-methoxycarbonylpentadecane-2-sulfonate orally by gavage.

Executive summary:

In a acute oral toxicity study, Crj: CD(SD)IGS male and female ratswere treatedSodium 1-methoxycarbonylpentadecane-2-sulfonate in the concentration of0, 786, 983, 1229, 1536, 1920, 2400 mg/kgorally by gavage in Olive oil. Deaths was observed 6 to 24 hours after administration in male rats at 983, 1229, 1536, 1920, 2400 mg/kg and in female rats at 1536, 1920, 2400 mg/kg.Decreased locomotor activity, ptosis, diarrhea, soiling of the perineal region and piloerection were observed in treated groups. Most clinical signs in the survivors showed a tendency for recovery on the day following administration and all had disappeared after 6 days. In addition, Dose dependent decrease in body weights were observed in treated male and female rats. However, a tendency for recovery was noted 3 days after the administration. Distention of the stomach with a watery content was observed in most of the animals which died. Therefore,estimated LD50 was considered to be 170000 mg/kg bw when rat were treateddisodium 4-oxo-2-sulfonato-5,8,11,14-tetraoxahexacosan-1-oate orally.