Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Male and female rats aged approximaeely 12 weeks, were used at each dose level. Four animals of one sex were housed in each cage. The animals were weighed, fasted overnight.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The calculated dose of material administered by intraoesophageal intubation using a ball point needle fitted to a syringe. After dosing food and water were freely available throughout a 9 day observation period
Doses:
200, 400, 800 and 1600 mg/L
No. of animals per sex per dose:
4 male and 4 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 800 mg/kg bw
Based on:
test mat.
Mortality:
2 male and 3 femalle at 800 mg/kg ; all animals at 1600 mg/kg
Clinical signs:
Rats showed signs of lethargy and died following a period of coma.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The LC50 via the oral route in rats was determined to be approximately 800 mg/kg bw.