Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (analytical purity not specified, no necropsy performed, limited documentation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
analytical purity not specified, no necropsy performed, limited documentation
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): Stearate D'Ethyl 2 Hexyl
- Physical state: no data
- Analytical purity: no data
- Lot/batch No.: 2826

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 22 g (males) and 20 g (females)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
4300 mg/kg bw (converted from 5 mL/kg bw, based on a density of 860 g/L)
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 4 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortalities observed, converted from 5 mL/kg bw based on a density of 860 g/L, see IUCLID Section "Physical and chemical properties, Density"
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs occurred during the study period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information