Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Basic data given (no details on test substance given, only limited data on results available)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Principles of method if other than guideline:
Acute toxicity was tested in male mice after receiving a single dose of the test item. The animals were observed over a time period of 6 days.
GLP compliance:
not specified
Test type:
other: no guideline followed

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, esters with diethylene glycol
EC Number:
285-550-1
EC Name:
Fatty acids, C16-18, esters with diethylene glycol
Cas Number:
85116-97-8
Molecular formula:
Not applicable as UVCB
IUPAC Name:
Fatty acids, C16-18, esters with diethylene glycol

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed until the end of the observation eriod.
Clinical signs:
other: No signs indicative for anomalies observed until the end of the observation period.
Body weight:
other body weight observations
Remarks:
body weight appeared normal.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008