Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
March 22, 1996
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
February 24, 1987
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Dated 31 July 1992
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Donor C20
IUPAC Name:
Donor C20
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Supplier: Charles River Wiga, Germany
Age: 5-6 weeks old upon arrival
identification: earmarked
Caging: five animals per cage (stainless stell cages, fitted with wire-screen floor and front)
Acclimatization: 9 or 13 days
Lighting: 12 hours light/dark cycle
Temperature: 22 +/- 3C
Ventilation: ca. 10 air changes/hr
Diet: standard chow ad libitum
Water: tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
Animals were dosed with a dosing volume of 10 ml/kg bw of a 200 mg/ml suspension of test material in maize oil to obtain the 2000 mg/kg dose level. The exact amount of the test substance to be dosed was calculated for each animal and administered by means of a syringe, by oral gavage. Animals fasted overnight prior to dosing and 4 hours after.
Doses:
2000 mg/kg limit dose
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Animals were observed for mortality 14 days post exposure.
Body weights of each animal were recorded immediately before dosing on day 0 and in the surviving animals on days 3, 7 and 14 of the study.
Animals were sacrificed on day 14 with CO2 and subjected to gross pathology.

Results and discussion

Preliminary study:
No mortality observed in 2 males.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female was found dead on day 3
Clinical signs:
blepharospasm in two males was observed
prior to death, the female showed sluggishness, blepharospasm, dyspnoea and coma
Body weight:
All surving animals gained weight during the study
Gross pathology:
No treatment related gross alterations was observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Since only one animal died during the 14 -day observation period, the oral LD50 of the test material is considered to exceed 2000 mg/kg body weight, in both male and female rats.