Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Six groups of 10 male young adult rats (160-180 g) were dosed at 1000, 3100, 4000, 5000, 6300 or 8200 mg/kg bw. The animals were observed for mortality, body weights, clinical signs and gross pathological changes through day 14.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
1000, 3100, 4000, 5000, 6300 or 8200 mg/kg bw
No. of animals per sex per dose:
Ten male animals per dose
Control animals:
no
Statistics:
Ld50 was calculated according to Fink and Hund, Arzneim.-forsch. 15, 624 (1965).

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
4 010 mg/kg bw
Based on:
test mat.
Mortality:
0% (1000 mg/kg bw), 30% (3100 mg/kg bw), 50% (4000 mg/kg bw), 60% (5000 mg/kg bw), 90% (6300 mg/kg bw), 100% (8300 mg/kg bw).
Clinical signs:
Clinical signs at 3100 mg/kg bw and above included tremor and bloody eyes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 = 4010 mg/kg bw (rat, male).
Executive summary:

Six groups of 10 male young adult rats (160-180 g) were dosed at 1000, 3100, 4000, 5000, 6300 or 8200 mg/kg bw by gavage. The animals were observed for mortality, body weights, clinical signs and gross pathological changes through day 14. A LD50 = 4010 mg/kg bw was found.