Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations 16, Part 1500.3 (USA)
Deviations:
no
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: oil
Details on test material:
a-ethyl-hexyl-oxystearate
Specific details on test material used for the study:
a-ethyl-hexyloxystearate
colourless liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Not detailed

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Observed for 2 weeks post-dose
Doses:
Single gavage at 8ml/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
8 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
Based on:
test mat.
Mortality:
2 animal died during the study period.
Clinical signs:
Not reported.
Body weight:
Not reported.
Gross pathology:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
20% of the animals used at the dose level of 8ml/kg died. LD50 is greater than 8ml/kg
Executive summary:

In this guideline (CFR 1500.3) study the LD0 of the test material was determined to be 8 ml/kg bw. 5 male and 5 female rats were dosed orally by gavage at 8 mL/kg and observed for 2 weeks post-dose. 2 deaths were observed.