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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
26 Mar - 09 Apr 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZEN-VEVOMIX
- Physical state / appearance: brown liquid
- Analytical purity: 100%
- Density: 1.31 g/mL (Determined at RCC NOTOX)
- Lot/batch No.: VVM 9109DPC12/100
- Expiration date of the lot/batch: August 1, 1992
- Storage condition of test material: in refrigerator in the dark
- Stability under storage conditions: stable

Test animals

Species:
rat
Strain:
other: Wistar strain, albino, outbred, SPF-quality
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 205-214 g; females: 164-178 g
- Fasting period before study: overnight prior to dosing until approx. 4 hours after administration of the test substance
- Housing: Group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (woody SPF, Broekman Institute, Someren, The Netherlands)
- Diet (ad libitum): standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland)
- Water (ad libitum): tap water; analysis performed quarterly
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSE VOLUME APPLIED: 3.817 mL/kg body weight (dose level (g/kg) / density (1.31 g/mL)


Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations for mortality / viability: twice daily
- Frequency of observations for clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter. The time of onset and duration were recorded.
- Frequency of weighing: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic abnormalities at necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
Signs of ill health or behavioural changes included piloerection, observed in three males and three females approximately 2 hours after dosing.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Mean body weight increase within 14 day observation period: males: 74 g, females: 35 g
Gross pathology:
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion