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Toxicological information

Acute Toxicity: oral

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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:
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 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.