Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-08-04 to 1989-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant; Guideline Study (OECD 401)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical properties: solid;
- Storage conditions: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF),
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited; Experimental Toxicology; 4332 Stein / Switzerland
- Age at study initiation: 6 to 8 weeks;
- Weight at study initiation:174 to 214 g;
- Fasting period before study: overnight,
- Housing: Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum;
- Water: tap water ad libitum;
- Acclimation period: at least 5 days;

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C;
- Humidity: 55 +/- 10 %.
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours dark/12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL;
- Amount of vehicle (if gavage): 10 mL;

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight;

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily; Weighing: on administration day, on day 7, and day 14;
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality occurred in this study.
Clinical signs:
Pilolerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 4 days.
Body weight:
Animals showed normal body weight gain.
Gross pathology:
At autopsy, no deviations from normal morphology were found.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU