Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards (without detailed documentation)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
5 mice per sex per dose were administerd a single dose of the test substance via intraperitoneal injection. Clinical signs and body weight were monitored and necropsy was carried out at termination (or after death, if it occured) on all animals. The animals were sacrificed on day 7 after application.
GLP compliance:
no
Remarks:
performed prior to the implemantation of GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Purity: 100%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ivanovas
- Weight at study initiation (mean): 27 g (males), 23 g (females)

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(0.5% aqueous solution)
Details on exposure:
35% solution of test substance in 0.5% CMC-solution
Doses:
6810 and 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: day 1 (several times), 5 and 8
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1 animal died within the 7 day observation period.
Mortality:
1 animal died within 48 h after application of the test substance (10000 mg/kg bw).
Clinical signs:
Dyspnoea, apathy, tremor
Body weight:
- Mean weight (6810 mg/kg bw): day 1: 26 g (males), 20 g (females); day 5: 27 g (males), 24 g (females); day 8: 28 g (males), 23 g (females)
- Mean weight (10000 mg/kg bw): day 1: 27 g (males), 23 g (females); day 5: 27 g (males), 24 g (females); day 8: 30 g (males), 26 g (females)
Gross pathology:
10000 mg/kg bw intra-abdominal substance residues (10/10 animals); slight adhesions and spleen enlargement (9/10 animals)

6810 mg/kg bw intra-abdominal substance residues; slight adhesions and megaly of the spleen

Applicant's summary and conclusion