Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-12-20 to 1992-03-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study (OECD 401)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

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

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 Animal Production; 4332 Stein / Switzerland;
- Initial body weight range: 173 to 195 g
- Husbandry: rats were kept in an animal room under conventional laboratory conditions
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle.
- Air changes (per hr): approximately 15 air changes per hour)
- Temperature: 22 +/- 2 °C
- Relative humidity: 55 +/- 10 %
- Housing: the rats were individually housed in Macrolon cages type 3, with standardized soft wood bedding
- Acclimatisation: rats were acclimatized for at least 5 days before exposure
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) and water were provided ad libitum

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:
- Volume applied: 10 mL/kg bw
Doses:
2000 mg/kg bw (males and females)
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Observation period: 14 days
- Prior to dosing, the animals were fasted overnight
- Frequency of observations and weighing:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Weighing: on day 0, 7, and 14
- Necropsy of survivors performed: yes


Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed during the observation period
Clinical signs:
Piloerection, hunched posture, dyspnea
Body weight:
No observable abnormalities
Gross pathology:
No observable abnormalities
Other findings:
All animals recovered within 3 days

Applicant's summary and conclusion

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