Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Squalane
Doses:
The rats were administered a single dose, oraly, by gavage of 2000mg/kg of body weight (of hydrogenated decyl olive oil esters at 10% in squalane).
Meaning the hydrogenated decyl olive oil esters dose was 200 mg/kg of body weight.
No. of animals per sex per dose:
5 males and 5 nulliparous and non-pregnant females
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 200 mg/kg bw
Mortality:
no mortality was observed during the 14 days of observation.
Clinical signs:
no clinical signs were observed during the 14 days of observation except for a slight piloerection on day 1 after treatment.
Body weight:
the animals gained body weight
Gross pathology:
none observed

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Executive summary:

The test substance at 10% in squalane had a LD50>2000mg/kg, meaning LD50>200mg/kg for pure substance.