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Toxicological information

Acute Toxicity: oral

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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

Reference
Name:
Unnamed
Type:
Constituent
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 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.