Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-10-18 to 1984-11-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Complete guideline conform study report available. Study is performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Hostacerin DGO
- Physical state: liquid, yellow
- Density: 0.97 g/cm3
- Composition of test material, percentage of components: 100% Diglycerinsesquoleat, 0.2% Antoxidant
- Lot/batch No.: FMFP355
-Storage condition: in the dark at about 22 °C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
No reduction in body weight gain.
Gross pathology:
No effect visible.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of above mentioned study the median lethal dose (LD50) of the test substance after single oral administration to male and female rats, observed over a period of 14 days is 5000 mg/kg bw.
Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered once per oral gavage as a solution in 25% sesame oil in Wistar rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as EU Method B.1 (Acute Toxicity (Oral)).

Ten fasted animals (five per sex) were given a single oral dose of test material at the dose level of 5000 mg/kg bw. No mortality occurred. No clinical signs were observed during the observation period of 14 days. No effect on body weight development was observed. At the end of the observation period all rats were sacrificed with CO2 gas. Gross pathological examination dit not reveal any alteration.

Based on the results of above mentioned study the median lethal dose (LD50) of the test substance after single oral administration to male and female rats, observed over a period of 14 days is 5000 mg/kg bw.