Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Korantin SC 9437 (now: Korantin MAT)
- Physical state: liquid
- Analytical purity: ca. 100 % (UVCB)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA
- Weight at study initiation: mean males: 254 g, mean females: 200 g
- Fasting period before study: 15-20 hours
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 21.5 %, 31.6 % and 50 %

MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg
Doses:
2150, 3160, 5000, 6810, 10000
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 and weighing: animals were observed daily, weighing was performed on day 0, day 2-4, day 7 and day 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 752 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 904 - <= 5 698
Mortality:
2150 mg/kg: no deaths
3160 mg/kg: 2/5 males and 0/5 females died
5000 mg/kg: 2/5 males and 2/5 females died
6810 mg/kg: 5/5 males and 4/5 females died
10000 mg/kg: all animals died
Clinical signs:
observed clinical signs included: dyspnea, stertor, apathy, abnormal position, staggering, paresis (hind leg), spastic gait, piloerection, erythema, exsiccosis, exophthalamus, salivation, blood (in the nose and/or in the urine), poor general state. Not all clinical signs were observed in all dose groups
Body weight:
animals that did not die gained weight
Gross pathology:
animals that died: Heart: acute atrial dilatation; acute congestive hyperemia; stomach: diffuse reddening of true stomach; intestines: atonic, mucosal reddening, diarrhea and hematinic contents.
sacrificed animals: nothing unusual was observed

Applicant's summary and conclusion