Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Vazo(R) 56 WSP
- Substance type: organic
- Physical state: solid
- Analytical purity: > 97 %
- Lot/batch No.: M0200
- Expiration date of the lot/batch: Not advised, but assumed to be stable for six months from date of receipt
- Storage condition of test material: stored at room temperature in the dark from date of receipt and at 4 °C in the dark from 10 December 1998

Test animals

Species:
rat
Strain:
other: HSD: Sprague-Dawley(CD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 94 - 130 g
- Fasting period before study: overnight before and 4 hours after gavage
- Housing: in groups of three, metal cages
- Diet: Special Diet Services RM1(E) SQC expanded pellet ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 or 20 w/v%
- Amount of vehicle (if gavage): 10 ml / kg bw
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): not required
- Purity: not requierd

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not stated
Doses:
200 mg/kg bw, 2000 mg/kg bw
No. of animals per sex per dose:
200 mg/kg bw 3 male, 3 female
2000mg /kg bw 3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation twice daily, weighing on day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
no statistics applied

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD100
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
all females dosed at 2000 mg /kg died during the study. All deaths occurred within approximately 70 minutes of dosing. Macroscopic examination revealed congestive changes in the brain and fluid contents in the stomach.
Clinical signs:
Piloerection was observed in all rats within four minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or later intervals during the study by;
hunched posture, waddling/unsteady gait, lethargy, abnormal respiration, pallid extremities notable in one or more animals treated at 200 and 2000 mg/kg, with partially closed eyelids, walking on toes, increased lacrimation, increased snsitivity to touch, ungroomed appearance, body tremors, prostration, blue/cold extremities and dark colouring to eyes in one female and increased salivation in one further female dosed at 2000 mg/kg only.
Body weight:
All animals surviving treatment were considered to have achieved satisfactory bodyweight gains throughout the study
Gross pathology:
No macroscopic abnormalities were observed for animals that survived treatment and killed at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose (LD50) to rats of the substance is demonstrated to be between 200 and 2000 mg/kg bodyweight.
By default, this is equivalent to LD50 = 500 mg / kg bw.