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:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Remarks:
GLP statement
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries, Cumberland, Indiana
- Age at study initiation: 'young'
- Weight at study initiation: approximately 220 ± 20 g
- Fasting period before study: about 16 hours
- Housing: individually housed in conventional design stainless steel, wire mesh bottom cages
- Diet: Purina Rodent Chow, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS: not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: all animals were weighed 24 hours, 7 days and 14 days after administration of the test material. The animals were observed frequently on the first day of dosing and twice a day thereafter at least four hours apart.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
one death - cause not fully known; post mortem examination revealed desquamation of the inner epithelium lining of the stomach and upper intestinal tract.
Clinical signs:
weakness, drowsiness
Body weight:
no obvious effects
Gross pathology:
no compound related major pathology in surviving animals

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance has been tested in an acute oral toxicity study conducted according to a guideline equivalent to OECD TG 401. The undiluted test substance was administered by gavage to 5 male and 5 female rats at 5000 mg/kg. All rats exhibited weakness and drowsiness for several hours after the treatment. One female rat died after one hour but the remaining animals appeared normal at 48 hours after treatment, and all remaining animals survived the 14 day observation period. Under the test conditions, the test substance has a very low acute oral toxicity. The LD50 was determined to be >5000 mg/kg bw.