Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 to 18 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions (analytical purity of test substance not specified, only female animals evaluated, only 6-day observation period in the absence of any sign of adverse toxicity, no necropsy, limited information on test animals/test animal husbandry).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
analytical purity of test substance not specified, only female animals evaluated, only 6-day observation period in the absence of any sign of adverse toxicity, no necropsy, limited information on test animals/test animal husbandry
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): oleate ethyl 2 hexyle
- Physical state: liquid, clear
- Batch/Lot Nr.: 2903 DL

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- NMRI EOPS mice were used in the study
- Weight at study initiation: 19 - 20 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
> 5 mL/kg, calculated from 5000 mg/kg bw, assuming test substance density of 870 mg/mL from chapter 4.4
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 (female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: daily, body weight before and at the end of the study.
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortalities or clinical signs of adverse toxicity observed at this unique dose level
Mortality:
No mortality occured during the study period.
Clinical signs:
No abnormality were observed up to the end of the observation period.
Body weight:
Normal body weight gain observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified