Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-08-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Study performed in accordance with the techniques specified in the US Regulations for the Enforcement of the Federal Hazardous Substances Act (Code of Federal Regulations, Title 16 Chapter II, 1976).

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

EC Number:

266-533-8

EC Name:

Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

Cas Number:

66988-04-3

Molecular formula:

C24H44O6.Na

IUPAC Name:

sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate

Specific details on test material used for the study:

- Test material name: Pationic ISL
- Source: C.J. Patterson Company
- Appearance: Thick clear yellow liquid with a slight odor
- Batch No. : Pl 06 24 77

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Industries, Inc.
- Females (if applicable) nulliparous and non-pregnant: Not applicable
- Weight at study initiation: 213–250 g
- Fasting period before study: 18 h
- Housing: Rtas were housed in groups in wire mesh cages suspended above droppings
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes

Administration / exposure

Route of administration:

other: via stomach tube

Vehicle:

unchanged (no vehicle)

Doses:

6.1 g/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: At frequent intervals during the day of dosage and atleast once thereafter for a total of 14 days
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 6 100 mg/kg bw

Based on:

test mat.

Mortality:

- Four mortalities (out of ten tested rats) occurred during the study with no signs of toxicity were noted in these rats prior to death.
- Three rats died within 5.5 hours following dosage.
- One rat was found dead on day 1.

Clinical signs:

- For the rats that died before the study ended, no clinical signs of toxicity were noted prior to death.
- Toxic signs in the survivors during the remainder of the day of dosage included depression in five rats and depressed righting and placement reflexes and laboured respiration in one rat.
- All survivors appeared normal on the first post-dosage day.
- From the second day, the survivors exhibited normal appearance and behaviour throughout the study with the exception of two rats with urine stains noted on day 3 and one to two rats with diarrhea noted on days 8, 9 and 10.

Body weight:

- The average body weight gain for the surviving rats was 111 g. This gain is normal for the rats of the age, sex and strain used in this study.

Gross pathology:

- Gross necropsies performed on the 3 rats that died 5.5 h following dosage revealed congested lungs and fluid in the pleural cavity in all the rats, congested adrenals in one rat and irritated intestinal tracts with a creamy yellow semi-solid in the stomach of two rats.
- Of the one rat that died on day 1 of dosage, the lungs were congested and the pleural cavity was filled with bloody appearing fluid. The kidneys were congested. The gastrointestinal tract was irritated, the stomach was filled with a yellow semi-solid and the peritoneal wall was wrinkled as well as advanced autolysis was noted. External urine stains were also observed.
- Necropsies performed at study termination of the surviving rats revealed no significant gross pathological alterations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of sodium isostearoyl lactylate was found to be greater than 6.1 g/kg bw in rats.

Executive summary:

In an acute toxicity study, 10 male Sprague-Dawley rats were administere orally sodium isostearoyl lactylate (Pationic ISL) via a stomach tube for 14 days. Clinical observations and body weights were recorded and necropsies were performed. Clinical signs included depression and minor behavioural and respiratory effects. Four mortalities (out of the 10 tested rats) were observed during the study. Based on these results, the LD50 of sodium isostearoyl lactylate in rats was determined to be greater than 6.1 g/kg bw.