Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1983-09-27, 1983-10-11
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:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Upon an acute intraperitoneal administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state Solid
- Stability under test conditions: Stable

Test animals

Species:
rat
Strain:
other: Tif:RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD., Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 184 - 243 g
- Fasting period before study: Yes, overnight
- Housing: groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): Ad libitum, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum):Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55+15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
arachis oil
Doses:
1000 mg/kg
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: daily, a.m. and p.m. on working days; body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Remarks on result:
other: Nominal
Mortality:
None
Clinical signs:
Dyspnoea, exophthalmus, ruffled fur and curved body position (Table 1).
Body weight:
Table 2
Gross pathology:
Peritoneal adhesions or pseudomembranes around the spleen, were found in all animals. In addition one female had adhesions around the kidneys.

Any other information on results incl. tables

Table 1: Signs and symptoms*

Dose: 1000 mg/kg
Observations Exposure day (h) Post-exposure period (D)
1 2 3 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Dyspnoea xx xx xx xx xx x x x x x x x











Exophothalmus x x x x x x x x x x















Ruffled fur xx xx xx xx xx x x x x x x













Curved body position x x x x x x x x x

















*) x = slight; xx = moderate; xxx = marked

Table 2. Body weights and standard deviation.

Dose mg/kg Males Females
day 1 day 7 day 14 day 1 day 7 day 14
1000 231±16 273±15.3 325±26.4 190±5.4 204±7.5 221±7.7

Applicant's summary and conclusion

Conclusions:
The test item has practically no acute toxicity when administered intraperitoneally to the albino rat.