Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-05-23 to 1997-04-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DR. K. THOMAE GMBH, BIBERACH, Germany
- Age at study initiation: Young adult animals of a comparable weight were used
- Weight at study initiation: males 180 - 183 g, females 169 - 171 g
- Fasting period before study: 16 hours prior to administration (but water ad libitum)
- Housing: Five animals per cage (type: stainless steel wire mesh cages, DK-III), no bedding
- Diet: KLIBA-LABORDIAET 343, KLINGENTALMUEHLE AG KAISERAUGST, SWITZERLAND, as libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data, however housing in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 1996-05-14 (day of first administration, before at least one week acclimatisation) To: 1996-05-23 (day of last administration)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bidest
Details on oral exposure:
The aqueous test substance formulation corresponds to the physiological medium.
Form of administration: emulsion

VEHICLE
- Concentration in vehicle: 20 g / 100 mL
- Amount of vehicle: 10 mL
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium
- Purity: bidest water was used

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/ kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: A check for dead and moribund animals was made twice on workdays and once on the other days. Weighing of both groups on day 0, day 7; on day 13 (males) and day 14 (females).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, impaired general state, poor general state, dyspnoea, apathy, staggering, piloerection, salivation, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Males only: impaired or poor general state, dysponea, apathy, staggering, salivation. These symptoms are considered to be unspecific toxicity symptoms. The animals appeared normal one day after administration.
Body weight:
Mean body weight of males: 182 g on day 0, 248 g on day 7, 281 g on day 13
Mean body weight of females: 170 g on day 0, 205 g on day 7, 214 g on day 13
The expected body weight has been observed in the course of the study.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion