Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-01-19 (day of dosing)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Uvinul N 539 T
- Physical state: liquid
- Analytical purity: 98.3 %
- Lot/batch No.: 505396-70182
- Stability under test conditions: confirmed
- Storage condition of test material: room temperature
No further data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
male and female Wistar rats (Chbb:Thom (SPF))
- Source: Dr. K Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult, no further data
- Weight at study initiation: 150 - 300 g
- Fasting period before study: 16 hours prior to dosing
- Housing: individually in stainless steel wire mesh cages, type III
- Diet (ad libitum): KLIBA Labordiät 343, Klingentalmühle AG, Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil
Details on oral exposure:
VEHICLE
olive oil DAB 9
- Concentration in vehicle: 500 g/L
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: The test substance is insoluble in water
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- individual body weights were determined shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period)
-- signs and symptoms were recorded several times on the day of dosing, at least once each workday for the individual animals
-- general observations and check for mortality was made twice each workday and once on saturdays/sundays/public holidays
- Necropsy of survivors performed: yes
-- food was withdrawn at least 16 hours before sacrifice with carbon dioxide; then, necropsy was made with gross pathological examination
-- necropsy of animals that dies before scheduled sacrifice was made as early as possible
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occurred.
Clinical signs:
Impaired general state, dyspnea, and piloerection were observed in one male rat. According to the authors, these symptoms were considered to be unspecific. The animal was normal on the day after treatment.
No clinical signs were recorded for the remaining four males and for the females.
Body weight:
Body weight and body weight gain was in the expected range.
mean body weights of the males: (187 g (day 0 = prior to dose), 252 g (day 7), 290 g (day 13)
mean body weights of the females: (180 g (day 0), 202 g (day 7), 215 g (day 13)
Gross pathology:
No pathological findings were noted.

Applicant's summary and conclusion