Fatty acids, C8-14 (even numbered) methyl-2-sulfoethyl esters, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

Read-across to DEFI

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This is a one page report with limited details provided. However, the results serve to indicate the low toxicity of the test substance.

Justification for type of information:

Refer to read-across justification document for SCMI in section 13

Cross-reference

Reason / purpose for cross-reference:

assessment report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Guideline:

other: In house method G.2.2.1.

Principles of method if other than guideline:

5 groups of male Sprague Dawley rats were given a single dose of DEFI (20% concentration) on day 1 doses of 3.3, 4.1, 5.1, 6.4 and 8.0 g/kg. Animals were observed for mortality and clinical signs on days 1, 2, 3, 4, 7 and 14, with bodyweight measured on days 0, 7 and 14.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts

EC Number:

287-024-7

EC Name:

Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts

Cas Number:

85408-62-4

IUPAC Name:

85408-62-4

Constituent 2

Reference substance name:

Sodium 2-sulphonatoethyl laurate

EC Number:

230-949-8

EC Name:

Sodium 2-sulphonatoethyl laurate

Cas Number:

7381-01-3

Molecular formula:

C14H28O5S.Na

IUPAC Name:

sodium 2-(dodecanoyloxy)ethanesulfonate

Details on test material:

- Name of test material (as cited in study report): Sodium Lauroyl Isethionate
- Molecular formula (if other than submission substance): Na.SO3-CH2-CH2-O-CO-(CH2)10-CH3
- Molecular weight (if other than submission substance): 344.419g/mol
- Smiles notation (if other than submission substance): [O-]S(=O)(CCOC(CCCCCCCCCCC)=O)=O.[Na+]
- InChl (if other than submission substance): no data
- Substance type: organic
- Physical state: aqueous solution
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): no data
- Specific activity (if radiolabelling): 36.8 X 10exp6 dpm/mL (1.7 uCi/mg)
- Locations of the label (if radiolabelling): 1st Carbon of Lauroyl chain
- Expiration date of radiochemical substance (if radiolabelling): no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 170-201g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: not reported

Doses:

Single doses of 3.3, 4.1, 5.1, 6.4 and 8.0 g/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and other overt signs on days 1, 2, 3, 4, 7, and 14. Body weights were measured on days 0, 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

Probit (E1-2)

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

8 400 mg/kg bw

Mortality:

Mortalities were observed in the two highest dose groups only. In the 8 g/kg group, 2 animals died on day 1 and 1 on day 2. In the 6.4 g/kg group one animal died on day 4.

Clinical signs:

Slight diarrhea was observed in two animals in the 4.1 g/kg dose within 1-2 hours after dosing. Moderate diarrhea was observed in two, four and five animals about 1 hour after dosing in the 5.1, 6.4, and 8.0 g/kg bw doses, respectively. Lethargy was observed in all 8.0 g/kg dose animals 1 hour after dosing. Some lethargy was also observed at about 22 hours in a single animal each at the 6.4 and 8.0 doses

Body weight:

No significant effects to body weight were observed.

Gross pathology:

Gross pathology at necropsy revealed no significant findings.
Moderate inflammation of the gastric mucosa was observed in the animals that died on day 1 and 2 in the 8.0 g/kg bw dose.

Any other information on results incl. tables

Mortalities were observed in the two highest dose groups only.   In the 8 g/kg group, 2 animals died on day 1 and 1 on day 2.  In the 6.4 mg/kg group one animal died on day 4.

Clinical signs were observed in all dose groups except the lowest (3.1 g/kg).  

Lethargy was observed in all 8 mg/kg dose group animals approximately 1 hour after dosing.  Some lethargy was also observed at about 22 hours in a single animal each at the 6.4 and 8.0 g/kg doses.

Diarrhoea was observed in the 4.1, 5.1, 6.4 and 8 g/kg dose groups.  Moderate diarrhoea was observed in two, four and five animals about 1 hour after dosing in the 5.1, 6.4, and 8.0 g/kg bw doses, respectively. Slight diarrhoea was observed in two animals in the 4.1 g/kg dose within 1-2 hours after dosing.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study performed similar to current guidelines DEFI is considered to be of low toxicity, with a LD50 of 8.4 g/kg.