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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:
1978-11-15 till 1978-12-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Performed before GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Limited reporting.
- 1 sex.
- Acclimation period and housing conditions are unknown.
GLP compliance:
not specified
Remarks:
Before GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Morwet B
IUPAC Name:
Morwet B
Test material form:
solid: granular
Details on test material:
Material: Petrochemicals Company, Inc. - Morwet B
Specific details on test material used for the study:
Commercial product.

Test animals

Species:
rat
Strain:
other: Sherman - Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Albino rats of the Sherman-Wistar strain
- Weight at study initiation: weighing between 200 and 300 gm
- Fasting period before study: 24 hours prior to dosing
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: a 20% w/v suspension in water (200 mg/ml)

MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg
Doses:
Dosage levels:
0,2 gm/kg
0,4 gm/kg
0,8 gm/kg
1,6 gm/kg
3,2 gm/kg
No. of animals per sex per dose:
5 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Weighing: Prior to dosing and final weight
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Remarks:
Based on interpolation to 50% mortality between 800 mg/kg bw (0% mortality) and 1600 mg/kg bw (60% mortality)
Effect level:
ca. 1 500 mg/kg bw
Based on:
test mat.
Mortality:
Dose level 1.6 gm/kg 3 animals died.
Dose level 3.2 gm/kg 5 animals died.
Clinical signs:
other: Dose level 0.2 gm/kg and 0.4 gm/kg animals were slightly lethargic (normal after 24 hours). Dose level 0.8 gm/kg animals were depressed (normal after 24 hours). Dose level 1.6 gm/kg animals were depressed and exhibited shallow respiration after 1 hour. Th
Gross pathology:
Gross pathologic examination revealed nothing remarkble in the surviving animals sacrified at the conclusion of the study.
Some Hemorrhaging of the upper G.I. tract was evident in the animlas that died.

Any other information on results incl. tables

Concentration: 200 mg/ml

Dosage Level

gm/kg

Number of Animals Dosed

Mortalities

Days

Total Dead

14 Days

Total Survived

14 Days

Initial Weight

gm

Final Weight

gm

1

2

3

4

5

6

7

8

9

10

11

12

13

14

0.2

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

240

280

0.4

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

215

250

0.8

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

260

280

1.6

5

2

1

0

0

0

0

0

0

0

0

0

0

0

0

3

2

240

255

3.2

5

5

-

-

-

-

-

-

-

-

-

-

-

-

-

5

0

235

-

Based on the results LD50 is around 1.5 gm/kg.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The subject material when studied in male albino rats has an acute oral LD50 of around 1500 mg/kg bw.
Executive summary:

There was limited reporting.

The study was performed with similarities to OECD Guideline 401 (Acute Oral Toxicity), but not according to GLP standards.

The test material, Morwet B, was evaluated for its acute oral toxicity potential in albino rats when administered as gavage doses at levels of 0.2, 0.4, 0.8, 1.6 and 3.2 gm/kg to males. No mortality occurred in animals dosed at the 0.2, 0.4 and 0.8 gm/kg level. At 1.6 g/kg bw 3/5 animals died between 8 and 30 hours, and at 3.2 g/kg bw all 5 animals died in less than 2 hours.

Clinical signs of toxicity included shallow respiration and depression. Gross pathologic examination revealed nothing remarkable in the surviving animals sacrificed at the conclusion of the 14 -day observation period. Some haemorrhaging of the upper G.I. tract was evident in the animals that died.

Conclusions: The LD50 is about 1500 mg/kg bw.