Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is pre-GLP and pre-OECD guidelines. The study has been performed according to a method similar to OECD 401

Data source

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

Materials and methods

Principles of method if other than guideline:
Pre-guideline study. Three doses suspended in 2% CMC were applied by gavage to each 5 male and 5 female rats. Observation period was 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Remarks:
migrated information: dispersion
Details on test material:
Test material dispersed in 2% Carboxymethylcellulose
- Physical state: solid, dispersed in 2% CMC

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: raised in-house at Ciba-Geigy Ltd. Switzerland, Sisseln
- Weight at study initiation: 160 to 180 grams
- Fasting period before study: overnight
- Housing: Macrolon cages type 3, groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hours dark, 10 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30%
Doses:
4640 mg/kg bw, 6000 mg/kg bw, 7750 mg/kg bw,
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After 1 and 2 hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology of organs
Statistics:
LD50 including 95% confidence limits were calculated with the logit model

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 6 231 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 5 723 - <= 6 957
Mortality:
Animals started to die after 7 days at 6000 mg/kg bw
Animals started to die after 24 hours at 7750 mg/kg bw
Clinical signs:
sedation, dyspnoea, exophtahlmos, curved positiona and ruffled fur
Body weight:
no data
Gross pathology:
no substance-related deviations from normal morphology observed in organs

Any other information on results incl. tables

Dose Died within
mg/kg bw 1 hour 24 hours 48 hours 7 days 14 days
m f m f m f m f m f
4640 5 5 0 0 0 0 0 0 0 0
6000 5 5 0 0 0 0 2 1 2 1
7750 5 5 1 0 2 2 5 5 5 5
 
                   
                     

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 in the rat is about 6200 mg/kg bw and similar in both sexes.
Executive summary:

The LD50 oral in the rat is ca. 6200 mg/kg bw.