Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: methological deficiencies (e.g. low number of animals, purity of TS not reported, no calculation of exact LD50 value) but carefully described observations

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1970
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Groups of 3 male and 3 female rats were given one intraperitoneal injection of 2.70, 1.35 or 0.68 g/kg and one group of 3 females was given 5.42 g/kg and the survivors observed for 7 days.The mortality was recorded, a gross and microscopical pathological examination was done.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: no data

Test animals

Species:
rat
Strain:
other: young adult Alderly Park strain
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: inert dispersing medium
Doses:
680, 1350, 2700, 5420 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
680 - 1 350 mg/kg bw
Sex:
female
Dose descriptor:
LC50
Effect level:
2 700 - 5 420 mg/kg bw

Any other information on results incl. tables

Immediately after dosing all animals showed signs of severe abdominal irritation and loss of muscle control. They became comatose on the higher doses and semi-comatose on the lower dosage. All dead animals showed signs of peritonitis. The surviving animals recovered from coma within 48 hours and showed signs of abdominal irritation during the test. They did not gain weight nomally. At autopsy all animals showed signs of peritonitis (some severe) and this was confirmed microscopically. Reduced spermatogenesis was noted in two males and all animals given 680 mg/jk bw showed and increase in mitosis of liver cells.

Applicant's summary and conclusion

Executive summary:

Groups of 3 male and 3 female rats were given one intraperitoneal injection of 2.70, 1.35 or 0.68 g/kg and one group of 3 females was given 5.42 g/kg and the survivors observed for 7 days.The mortality was recorded, a gross and microscopical pathological examination was done.

LD50 = 680 -1350 mg/kg (rat, male, ip), LD50 = 2700 -5420 mg/kg bw (rat, female, ip)