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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-04-01 to 1987-05-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD), non-GLP but internally audited.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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, 7950 Biberach, Germany
- Age at study initiation: not specified
- Weight at study initiation: "comparable" (+/- 20% of the mean weight)
- Fasting period before study: 16 h
- Housing: Stainless steel wire mesh cage (Type DK III)
- Diet: ad libitum (except during fasting)
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 1987-04-01 to 1987-05-24

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50, 31.6, 21.5, 10, 4.64 mg / mL (w/v)
- Amount of vehicle: 0.5% CMC in water
- Justification for choice of vehicle: "Aqueous formulation corresponds to the physiological medium"

MAXIMUM DOSE VOLUME APPLIED: 10 mL / kg bw

Doses:
1500, 948, 645, 300, 139 mg/kg bw, calculated (30%) from original dosages:
5000, 3160, 2150, 1000, 464 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
a) signs and syptoms: several times on the day of application, at least once daily on workdays thereafter;
b) moribund or dead animals: twice daily on workdays and once daily on public holidays
- Frequency of weighing: Once at beginning of test, d6 or d7, d13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 380 mg/kg bw
Based on:
test mat.
Remarks on result:
other: interpolated (from 30% solution)
Mortality:
5000 mg/kg bw: males: 2 within one day; females: 5 within one day
3160, 2150, 1000 and 464 mg/kg bw: no mortality
Clinical signs:
Dyspnea, apathy, abnormal position, staggering, atonia, paresis, piloerection, cyanosis, poor general state
Body weight:
Mean weight males:
5000 mg/kg bw:: 192 (d0); 250 (d7); 291 (d13)
3160 mg/kg bw:: 190 (d0); 246 (d6); 283 (d13)
2150 mg/kg bw:: 188 (d0); 253 (d7); 283 (d13)
1000 mg/kg bw:: 189 (d0); 270 (d7); 302 (d13)
464 mg/kg bw:: 181 (d0); 258 (d7); 286 (d13)

Mean weight females:
5000 mg/kg bw:: 172 (d0)
3160 mg/kg bw:: 180 (d0); 205 (d6); 217 (d13)
2150 mg/kg bw:: 189 (d0); 223 (d7); 232 (d13)
1000 mg/kg bw:: 182 (d0); 216 (d7); 222 (d13)
464 mg/kg bw:: 180 (d0); 214 (d7); 223 (d13)
Gross pathology:
Perished males and females: General congestion. Stomach: mucosa of glandular stomach reddened, partly white
Sacrificed males and females: no pathologic findings
Other findings:
No

Applicant's summary and conclusion