Dodecanoic acid, 1-methyl-2-sulfoethyl ester, sodium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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.

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, coco, 2-sulfoethyl esters, sodium salts

EC Number:

263-052-5

EC Name:

Fatty acids, coco, 2-sulfoethyl esters, sodium salts

Cas Number:

61789-32-0

Molecular formula:

C10H20O5S.Na-C20H40O5S.Na

IUPAC Name:

Fatty acids, coco, 2-sulfoethyl esters, sodium salts

Details on test material:

- Name of test material:Directly Esterified Fatty Isethionate (DEFI) identified by Unilever as a 20% concentration (Sodium cocoyl isethionate).

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:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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