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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982/09/06 to 1982/09/20

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Full study report not available just a 1 page summary. Non GLP/guideline. No substance analytical information. Test item called DEFI which is Sodium Lauroyl Isethionate.

Data source

Reference

Reference Type:

other: Summary report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Limited information in report which states study was an acute oral toxicity study which resulted in the derivation of an LD50

GLP compliance:

not specified

Test type:

other: LD50

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Test itemnamed in report as Directly Esterified Fatty Isethionate (DEFI).
No further details on test item identity provided.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No information
- Age at study initiation: no information
- Weight at study initiation: 170-201 g
- Fasting period before study: no information
- Housing: no information
- Diet (e.g. ad libitum): no information
- Water (e.g. ad libitum): no infomation
- Acclimation period: no information


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no information
- Humidity (%): no information
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): no information


IN-LIFE DATES: From: Unknown

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: no data


DOSAGE PREPARATION (if unusual): no data


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data

Doses:

3.3, 4.1, 5.1, 6.4 and 8.0 grams/kg

No. of animals per sex per dose:

5 males per dose (no females)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 1,2,3,4, 7 and 14 following dosing
- Necropsy of survivors performed: no data but gross pathology stated to show no significant findings
- Other examinations performed:
Clinical signs=
Dose of 8.0 g/kg: Lethargy and moderate diarrhea observed in all animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
Dose of 6.4 g/kg: Moderate diarrhea observed in four animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
Dose of 5.1 g/kg: Moderate diarrhea observed in two animals approximately 1 hour after dosing.
Dose of 4.1 g/kg: Slight diarrhea observed in two animals approximately 2 hours after dosing.
Mean Body weights recorded at days 0, 7 and 14
Dose of 8.0g/kg: Day 0= 171g, day 7= 233g, day 14= 275g
Dose of 6.4g/kg: Day 0= 185g, day 7= 242g, day 14= 275g
Dose of 5.1g/kg: Day 0= 181g, day 7= 249g, day 14= 288g
Dose of 4.1g/kg: Day 0= 192g, day 7= 258g, day 14= 279g
Dose of 3.3g/kg: Day 0= 193g, day 7= 261g, day 14= 288g
Gross Pathology at Necropsy: No significant findings
8.0 g/kg: Day 1 - 2/2 moderate inflammation of the gastric mucosa.
Day 2 - 1/1 moderate inflammation of the gastric mucosa.

Statistics:

No data.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 8.4 other: g/kg bw

Remarks on result:

other: No confidence limits calculated

Mortality:

Dose of 8.0g/kg: 3/5 (2 died on day 1, 1 died on day 2)
Dose of 6.4g/kg: 1/5 (1 died on day 4)
Dose of 5.1g/kg: 0/5
Dose of 4.1g/kg: 0/5
Dose of 3.3g/kg: 0/5

Clinical signs:

8.0 g/kg: Lethargy and moderate diarrhea observed in all animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
6.4 g/kg: Moderate diarrhea observed in four animals approximately 1 hour after dosing. Lethargy observed in one animal approximately 22 hours after dosing.
5.1 g/kg: Moderate diarrhea observed in two animals approximately 1 hour after dosing.
4.1 g/kg: Slight diarrhea observed in two animals approximately 2 hours after dosing.

Body weight:

Dose of 8.0g/kg: Day 0= 171g, day 7= 233g, day 14= 275g
Dose of 6.4g/kg: Day 0= 185g, day 7= 242g, day 14= 275g
Dose of 5.1g/kg: Day 0= 181g, day 7= 249g, day 14= 288g
Dose of 4.1g/kg: Day 0= 192g, day 7= 258g, day 14= 279g
Dose of 3.3g/kg: Day 0= 193g, day 7= 261g, day 14= 288g

Gross pathology:

No significant findings
8.0 g/kg: Day 1 - 2/2 moderate inflammation of the gastric mucosa.
Day 2 - 1/1 moderate inflammation of the gastric mucosa.

Other findings:

No data

Any other information on results incl. tables

See results above.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In an acute oral toxicity study in the male rat, the LD50 was identified as 8.4g/kg bw and as such determined to be non toxic.

Executive summary:

In an acute oral toxicity study in the male rat, the LD50 was identified as 8.4g/kg bw and as such determined to be non toxic.