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Diss Factsheets

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:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
slight variations of humidity beyond the norms (30 to 70%RH) with a maximum at 79% RH
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
DiCOA
IUPAC Name:
DiCOA
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
10% suspension in a 1% aqueous dispersion of CMC
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
main study: test article as a 10% (w/v) suspension, pH=5.2, T=16.6°C
Examinations 15 min after intubation, then at 1, 2 and 4 h then each day for 14 days

Results and discussion

Preliminary study:
test article as a 2.5%, 5%, 10% w/v suspension in the vehicle
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality was observed
Clinical signs:
other: There were no changes in behavior or clinical signs in any of the treated animals during the observation period.
Gross pathology:
There were no macroscopic findings that could be associated with treatment.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50, by the oral route , in the rat (male+female) >2000 mg/kg